Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

Accreditation Scheme for Conformity Assessment Pilot Program

ASCA-Pilot-Guidance

Requirements for participating in pilot program: Accreditation Scheme for Conformity Assessment

OMB: 0910-0889

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0889 can be found here:

2023-06-30 - Extension without change of a currently approved collection

Document [pdf]

Download: pdf | pdf

Contains Nonbinding Recommendations

For questions about this document regarding CDRH-regulated devices, contact the ASCA Pilot
Program at ASCA@fda.hhs.gov. For questions about this document regarding CBER-regulated
devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
The OMB control number for this information collection is 0910-0889 (expires 06-30-2023).

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations

Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2019-D-3805. Comments may not be acted
upon by the Agency until the document is next revised or updated.

Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document
number 17037 and the complete title of the guidance in the request.

CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
WO71, Room 3128, Silver Spring, MD 20993, or by calling 1-800-835-4709 or 240-402-8010,
by email, ocod@fda.hhs.gov or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/biologics-guidances

Contains Nonbinding Recommendations

Table of Contents
I.

Introduction ............................................................................................................................. 1

II.

Background ............................................................................................................................. 2

III. Overview ................................................................................................................................. 3
IV. Scope ....................................................................................................................................... 4
V.

Terminology in the ASCA Pilot ............................................................................................. 6

VI. Purpose of the ASCA Pilot ..................................................................................................... 9
VII. Specific Goals of the ASCA Pilot......................................................................................... 10
VIII.Development of the ASCA Pilot........................................................................................... 12
A.

Stakeholder Input ........................................................................................................... 12

Conformity Assessment Resources ................................................................................ 12

Selection of FDA-Recognized Consensus Standards and Test Methods ....................... 14

ASCA Program Specifications Development ................................................................ 14

IX. Roles and Responsibilities .................................................................................................... 15

Accreditation Bodies ...................................................................................................... 15

Testing Laboratories ....................................................................................................... 15

Device Manufacturers .................................................................................................... 16

FDA Staff ....................................................................................................................... 16

Processes and Policies for Accreditation Bodies .................................................................. 17
A.

Qualifications for ASCA Recognition ............................................................................. 17

Accreditation Body Application Process ....................................................................... 18

Extension of ASCA Recognition ..................................................................................... 18

Requests for Clarification............................................................................................... 19

Audits of Accreditation Bodies ...................................................................................... 20

Withdrawal of ASCA Recognition .................................................................................. 21

XI. Processes and Policies for Testing Laboratories ................................................................... 23
A.

Qualifications for ASCA Accreditation .......................................................................... 23

Testing Laboratory Application Process ........................................................................ 24

Extension of ASCA Accreditation ................................................................................. 25

Requests for Clarification............................................................................................... 25

Audits of Testing Laboratories ....................................................................................... 26

Suspension of ASCA Accreditation ................................................................................ 27

Withdrawal of ASCA Accreditation ............................................................................... 30

XII. Processes and Policies for Device Manufacturers ................................................................ 33

iii

Contains Nonbinding Recommendations
A.

Selection of an ASCA-accredited Testing Laboratory ................................................... 33

Development of a Test Plan ........................................................................................... 33

Contents of a Premarket Submission ............................................................................. 35

XIII.Processes and Policies for FDA Review Staff ...................................................................... 36
A.

General Premarket Review Policy ................................................................................. 36

Impact of Suspension of ASCA Accreditation................................................................ 37

Impact of Withdrawal of ASCA Accreditation ............................................................... 38

XIV.

Paperwork Reduction Act of 1995 ................................................................................. 38

Appendix A: Application for ASCA Recognition ......................................................................... 40
A.

Administrative Information ............................................................................................ 40

Scope of ASCA Recognition ........................................................................................... 40

Information in Support of Competence .......................................................................... 40

Signed Agreement .......................................................................................................... 41

Appendix B: Application for ASCA Accreditation ....................................................................... 43
A.

Administrative Information ............................................................................................ 43

Scope of ASCA Accreditation ........................................................................................ 43

Information in Support of Competence .......................................................................... 43

Signed Agreement .......................................................................................................... 43

Contains Nonbinding Recommendations

The Accreditation Scheme for
Conformity Assessment (ASCA)
Pilot Program
Guidance for Industry, Accreditation
Bodies, Testing Laboratories, and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff or Office responsible for this guidance as listed on the title page.

Introduction

The Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the
ASCA Pilot) is authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).1 In accordance with amendments made to section 514 by the FDA Reauthorization
Act of 2017 (FDARA),2 and as part of the enactment of the Medical Device User Fee
Amendments of 2017 (MDUFA IV),3 FDA was directed to issue a guidance regarding the goals
and implementation of the ASCA Pilot.4 The establishment of the goals, scope, procedures, and a
suitable framework for the voluntary ASCA Pilot supports the Agency’s continued efforts to use
its scientific resources effectively and efficiently to protect and promote public health. FDA
believes the voluntary ASCA Pilot may further encourage international harmonization of
medical device regulation because it incorporates elements, where appropriate, from a wellestablished set of international conformity assessment practices and standards (e.g., ISO/IEC
17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory
or regulatory requirements governing the decision-making process for premarket submissions.

21 U.S.C. 360d(d)
See Pub. L. 115-52
3
See also MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download
4
See section 514(d)(3)(B) of the FD&C Act.
2

Contains Nonbinding Recommendations
This guidance refers to voluntary consensus standards.5 For the current edition of the FDArecognized consensus standard(s) referenced in this document, see the FDA Recognized
Consensus Standards Database.6 For more information regarding use of standards in regulatory
submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices7 and Standards Development and the
Use of Standards in Regulatory Submissions Reviewed in CBER.8
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidance means that something is suggested or
recommended, but not required.

II. Background
FDARA amended section 514 of the FD&C Act by adding a new subsection (d) titled “Pilot
Accreditation Scheme for Conformity Assessment.”9 Subsection 514(d) requires FDA to
establish a pilot program under which testing laboratories may be accredited by accreditation
bodies meeting criteria specified by FDA to assess the conformance of a device within certain
FDA-recognized consensus standards. Determinations by accredited testing laboratories that a
device conforms with an eligible standard included as part of the pilot program shall be accepted
by FDA for the purposes of demonstrating such conformity unless FDA finds that a particular
such determination shall not be so accepted.10
The statute provides that FDA may review determinations by accredited testing laboratories,
including by conducting periodic audits of such determinations or processes of accreditation
bodies or testing laboratories.11 Following such a review, or if FDA becomes aware of
information materially bearing on safety or effectiveness of a device tested by an accredited
testing laboratory, FDA may take additional measures as determined appropriate, including
suspension or withdrawal of accreditation of a testing laboratory12 or a request for additional
information regarding a specific device.13

For the purposes of this guidance, the term ‘standard’ or ‘standards’ will be used to refer to ‘consensus standard’ or
‘consensus standards’.
6
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
7
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices
8
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-developmentand-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation
9
See Pub. L. 115-52, section 205
10
See section 514(d)(1)(B) of the FD&C Act.
11
See section 514(d)(2)(A) of the FD&C Act.
12
Section 514(d)(2)(B) allows FDA to take additional measures “such as suspension or withdrawal of accreditation
of such testing laboratory.” As used in this guidance, the term “accreditation” refers to the “ASCA Accreditation”
granted by FDA and not the accreditation granted by an accreditation body.
13
See section 514(d)(2)(A)-(B) of the FD&C Act.

Contains Nonbinding Recommendations

III. Overview
Under the ASCA Pilot’s conformity assessment scheme, ASCA-recognized accreditation bodies
accredit testing laboratories using ISO/IEC 17025:2017: General requirements for the
competence of testing and calibration laboratories and the ASCA program specifications
associated with each FDA-recognized consensus standard and test method included in the ASCA
Pilot. The FDA-recognized consensus standards and test methods eligible for inclusion in the
ASCA Pilot and the ASCA program specifications are provided in the relevant standards-specific
ASCA Pilot guidance documents which can be accessed from the ASCA website.14
ASCA-accredited testing laboratories may conduct testing to provide data used to determine
conformance of a device with one or more of the FDA-recognized consensus standards and test
methods eligible for inclusion in the ASCA Pilot.
When an ASCA-accredited testing laboratory conducts testing under the ASCA Pilot, it should
provide to the device manufacturer all information listed in the relevant ASCA program
specifications, including an ASCA summary test report. Example ASCA summary test reports
for the FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA
Pilot are provided in the associated standards-specific ASCA Pilot guidance documents.
Device manufacturers may choose to use an ASCA-accredited testing laboratory to conduct
testing for premarket submissions to FDA. A device manufacturer that uses an ASCA-accredited
testing laboratory to perform testing in accordance with the provisions of the ASCA Pilot can
then include a declaration of conformity (DOC) with any necessary supplemental documentation
(e.g., an ASCA summary test report) as part of a premarket submission to FDA. Testing
performed by an ASCA-accredited testing laboratory can be used to support a premarket
submission for any device if the testing was conducted using an FDA-recognized consensus
standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the
ASCA program specifications for that standard.
During the ASCA Pilot, FDA generally will accept determinations from ASCA-accredited
testing laboratories (i.e., test results) when accompanied by a DOC and appropriate supplemental
documentation (e.g., an ASCA summary test report) and when the standard and test methods are
within the testing laboratory’s scope of ASCA Accreditation at the time of testing (Refer to
Section XIII. of this guidance).
As part of the enactment of MDUFA IV,15 FDA committed to publish the following information
on FDA’s publicly-accessible ASCA website:
-

A list of ASCA-recognized accreditation bodies including the FDA-recognized consensus
standards and test methods within the scope of each accreditation body’s ASCA
Recognition;

ASCA website: https://www.fda.gov/medical-devices/standards-and-conformity-assessmentprogram/accreditation-scheme-conformity-assessment-asca
15
MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download

Contains Nonbinding Recommendations
-

A list of ASCA-accredited testing laboratories including the FDA-recognized consensus
standards and test methods within the scope of each testing laboratory’s ASCA
Accreditation.

To further promote transparency, FDA intends to also identify an expiration date for each
accreditation body’s ASCA Recognition, and for each testing laboratory’s ASCA Accreditation,
on the publicly-accessible ASCA website. Figure 1 illustrates the process flow for the ASCA
Pilot as described above and in Sections IX and X of this guidance.

Figure 1 Process flow for the ASCA Pilot.

IV. Scope
Several complementary guidance documents are being used to implement the ASCA Pilot. This
guidance describes the goals and implementation of the ASCA Pilot as required by section
514(d)(3)(B) of the FD&C Act. Specifically:

Contains Nonbinding Recommendations
·

The “criteria specified by the Secretary”16 used to determine whether and how an
accreditation body or testing laboratory may participate in the ASCA Pilot. These criteria
include:
o Qualifications FDA intends to consider when reviewing applications from
accreditation bodies and testing laboratories to participate in the ASCA Pilot
(Refer to Sections X.A. and XI.A. of this guidance);
o Processes FDA intends to follow, including recommended application contents, in
granting ASCA Recognition to accreditation bodies and granting ASCA
Accreditation to testing laboratories (Refer to Sections X.B. and XI.B. of this
guidance);
o Terms of participation to which ASCA-recognized accreditation bodies and
ASCA-accredited testing laboratories agree (Refer to Section D of Appendices A
and B of this guidance); and
o ASCA program specifications associated with each eligible FDA-recognized
consensus standard and test method developed to communicate expectations for
how ASCA-recognized accreditation bodies accredit testing laboratories in the
ASCA Pilot.
§ This guidance document provides a description of how the ASCA program
specifications were developed (Refer to Section VIII.D. of this guidance).
ASCA program specifications are located in the relevant standardsspecific ASCA Pilot guidance documents.
The “certain standards recognized under [section 514]”17 eligible for inclusion in the
ASCA Pilot.
o This guidance document provides a description of how FDA-recognized
consensus standards and test methods were selected for the ASCA Pilot, including
considerations articulated in the MDUFA IV Commitment Letter18 (Refer to
Section VIII.C. of this guidance). The FDA-recognized consensus standards and
test methods eligible for inclusion in the ASCA Pilot are located in the relevant
standards-specific ASCA Pilot guidance documents.
The process by which device manufacturers may incorporate testing from ASCAaccredited testing laboratories in a submission to FDA for the purpose of demonstrating
conformance of a device with FDA-recognized consensus standards and test methods
eligible for inclusion in the ASCA Pilot19 (Refer to Section XII. of this guidance).
The policy regarding Agency review of determinations (i.e., test results) by ASCAaccredited testing laboratories. Such determinations “shall be accepted by the Secretary
for purposes of demonstrating such conformity under this section unless the Secretary
finds that a particular such determination shall not be so accepted”20 (Refer to Section
XIII. of this guidance).

See section 514(d)(1)(A) of the FD&C Act.
See section 514(d)(1)(A) of the FD&C Act.
18
See MDUFA IV Commitment Letter pg. 14: https://www.fda.gov/media/100848/download
19
See section 514(d)(1)(B) of the FD&C Act.
20
See section 514(d)(1)(B) of the FD&C Act.
17

Contains Nonbinding Recommendations
·

The processes and policies FDA intends to follow when “conducting periodic audits of
such determinations or processes of accredited bodies or testing laboratories”21 (Refer to
Sections X.E. and XI.E. of this guidance).
The processes and policies FDA intends to follow regarding “suspension or withdrawal
of accreditation” or “requesting additional information”22 (Refer to Sections X.F., XI.F.,
XI.G., and XIII.B. of this guidance).

The FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA
Pilot are identified in the relevant ‘standards-specific’ ASCA Pilot guidance documents. These
guidance(s) were developed for the purpose of being able to implement the framework described
in this guidance and provide more detailed information for the FDA-recognized consensus
standards and test methods eligible for inclusion in the ASCA Pilot. Each standards-specific
ASCA Pilot guidance document includes the following information:
·

·
·
·
·

Detailed list of FDA-recognized consensus standards and test methods eligible for
inclusion in the ASCA Pilot for assessment of the particular subject matter (e.g.,
biocompatibility testing);
ASCA program specifications associated with such standards and test methods;
Recommended premarket submission contents specific to such standards and test
methods when testing is conducted by an ASCA-accredited testing laboratory;
Example ASCA summary test report(s) for such standards and test methods; and
Example DOC for such standards and test methods.

The ASCA Pilot guidance documents do not address specific content for a particular premarket
submission. For more information about the use of standards for device review, visit the
Standards and Conformity Assessment Program website.23 See also FDA’s guidance, CDRH
Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus
Standards for Recognition24 FDA’s guidance, Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices, and FDA’s guidance Standards
Development and the Use of Standards in Regulatory Submissions Reviewed in CBER.
This guidance document is not intended to be a complete resource for understanding conformity
assessment. Key conformity assessment resources used to develop the ASCA Pilot are described
in Section V. of this guidance.

Terminology in the ASCA Pilot

This section provides definitions for key terms used in the ASCA Pilot. Where possible, FDA
has used terms already defined in the international standard ISO/IEC 17000:2004 Conformity
assessment – Vocabulary and general principles (hereafter referred to as “ISO/IEC 17000”) and

See section 514(d)(2)(A) of the FD&C Act.
See section 514(d)(2)(A) and 514(d)(2)(B) of the FD&C Act.
23
Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standardsand-conformity-assessment-program
24
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cdrh-standardoperating-procedures-identification-and-evaluation-candidate-consensus-standards-0
22

Contains Nonbinding Recommendations
ISO/IEC 17011 ISO/IEC 17011:2017: Conformity assessment – Requirements for accreditation
bodies accrediting conformity assessment bodies (hereafter referred to as “ISO/IEC 17011”).
Footnotes in this section indicate when a term is identical to one used in ISO/IEC 17000 or
ISO/IEC 17011. Some definitions within ISO/IEC 17000 and ISO/IEC 17011 refer to
“requirements;” FDA’s references to them for the ASCA Pilot do not make them legal or
regulatory requirements. In certain circumstances, FDA has created new terminology to describe
specific aspects of the ASCA Pilot.
·

·
·

25
26

Accreditation: third-party attestation related to a conformity assessment body conveying
formal demonstration of its competence to carry out specific conformity assessment
tasks.25 An accreditation body may or may not accredit a testing laboratory independent
of a laboratory’s participation (or desire to participate) in the ASCA Pilot.
Accreditation body: authoritative body that performs accreditation.26
ASCA-accredited testing laboratory: testing laboratory that has been granted ASCA
Accreditation by FDA. ASCA-accredited testing laboratories may label their testing as
having been conducted under the ASCA Pilot if the FDA-recognized consensus standards
and test methods were within their scope of ASCA Accreditation at the time of testing.
ASCA-accredited testing laboratories attend training, communicate with FDA, receive
periodic audits, and agree to follow the other processes and policies outlined in this
guidance (Refer to Section XI. of this guidance).
ASCA-recognized accreditation body: accreditation body that has been granted ASCA
Recognition by FDA. ASCA-recognized accreditation bodies may label their
accreditation activities as having been conducted under the ASCA Pilot if the FDArecognized consensus standards and test methods were within their scope of ASCA
Recognition at the time of accreditation; ASCA-recognized accreditation bodies attend
training, communicate with FDA, receive periodic audits, and agree to follow the other
processes and policies outlined in this guidance (Refer to Section X. of this guidance).
ASCA Accreditation: status granted by FDA to testing laboratories that demonstrate
competence in testing via the application process (Refer to Section XI.B. of this
guidance). ASCA-accredited testing laboratories are granted a scope of ASCA
Accreditation indicating the standards and test methods for which testing may be labeled
as having been conducted under the ASCA Pilot. ASCA Accreditation exists only within
the ASCA Pilot and is separate from any accreditation that an accreditation body may
provide to a testing laboratory for purposes other than the ASCA Pilot.
ASCA Recognition: status granted by FDA to accreditation bodies that demonstrate
competence in accreditation activities via the application process (Refer to Section X.B. of
this guidance). ASCA-recognized accreditation bodies are granted a scope of ASCA
Recognition indicating the standards and test methods for which accreditation activities
may be labeled as having been conducted under the ASCA Pilot.
ASCA summary test report: documentation that summarizes the testing conducted by an
ASCA-accredited testing laboratory within the scope of its ASCA Accreditation; an

Per ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles
Ibid

Contains Nonbinding Recommendations

·
·

·
·
·

ASCA summary test report is specific to the ASCA Pilot and should include the
information recommended in the standards-specific ASCA Pilot guidance documents.
Audit: systematic, independent, documented process for obtaining records, statements of
fact or other relevant information and assessing them objectively to determine the extent
to which specified requirements are fulfilled.27
o In the ASCA Pilot, FDA uses the term “audit” to refer also to evaluations and
assessments.
Conformity assessment: demonstration that specified requirements relating to a product,
process, system, person, or body are fulfilled; note that the subject field of conformity
assessment may include testing, inspection, and certification, as well as accreditation of
conformity assessment bodies.28
Conformity assessment body: body that performs conformity assessment services; note
that an accreditation body is not a conformity assessment body.29
Conformity assessment scheme: conformity assessment system related to specified
objects of conformity assessment to which the same specified requirements, specific rules
and procedures apply.30
Conformity assessment system: rules, procedures, and management for carrying out
conformity assessment.31
Declaration of conformity (DOC): attestation made by a medical device manufacturer, in
accordance with section 514(c)(1)(B) of the FD&C Act, regarding whether a device
conforms with an FDA-recognized consensus standard.32
Determinations by testing laboratories:33 test results.
Extending accreditation: adding conformity assessment activities to the scope of
accreditation.34
Extending ASCA Accreditation: adding FDA-recognized consensus standards and test
methods to a testing laboratory’s scope of ASCA Accreditation (Refer to Section XI.C. of
this guidance).
Extending ASCA Recognition: adding FDA-recognized consensus standards and test
methods to an accreditation body’s scope of ASCA Recognition (Refer to Section X.C. of
this guidance).

Ibid
Ibid
29
Ibid
30
Per ISO/IEC 17000, conformity assessment scheme setup varies based on the object of conformity assessment
(e.g., medical device), the users of the scheme (e.g., regulators, medical device manufacturers), and the nature of the
specific requirements being assessed (e.g., specific medical device standards).
31
Per ISO/IEC 17000
32
See FDA’s guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices.
33
The term “determinations by testing laboratories” is used in sections 514(d)(1)(b), 514(d)(2), and 514(d)(4) of the
FD&C Act.
34
Per ISO/IEC 17011
28

Contains Nonbinding Recommendations
·

·
·

·
·
·

FDA-recognized consensus standard: standards identified by FDA (per section 514(c) of
the FD&C Act) as appropriate for manufacturers of products to declare conformance to
meet relevant requirements under the FD&C Act, including premarket submission
requirements. For more information on the standards recognition process, please visit the
Standards and Conformity Assessment Program website35 and review FDA’s guidance
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices.
Request for Clarification: request submitted to FDA for clarification of one or more
specific ASCA program specifications from an ASCA-recognized accreditation body
(Refer to Section X.D. of this guidance) or an ASCA-accredited testing laboratory (refer
to Section XI.D. of this guidance). A Request for Clarification presents a question relative
to implementation of ASCA program specifications. It does not include suggestions or
requests for modifications to the ASCA Pilot or hypothetical issues.
Scope of accreditation: specific conformity assessment activities for which accreditation
is sought or has been granted.36
Scope of ASCA Accreditation: list of FDA-recognized consensus standards and test
methods for which a testing laboratory has demonstrated competence to FDA, through
the application process, for conducting testing for the ASCA Pilot.
Scope of ASCA Recognition: list of FDA-recognized consensus standards and test
methods for which an accreditation body has demonstrated competence to FDA, through
the application process, for accrediting testing laboratories for the ASCA Pilot.
Suspending ASCA Accreditation: putting temporary constraints in place for one or more
FDA-recognized consensus standards or test methods within a testing laboratory’s scope
of ASCA Accreditation (Refer to Section XI.F. of this guidance).
Third-party attestation: issue of statement, based on a decision following review, that
fulfilment of specific requirements has been demonstrated.37
Withdrawing accreditation: cancelling accreditation for the full scope.38
Withdrawing ASCA Accreditation: cancelling a testing laboratory’s full scope of ASCA
Accreditation; withdrawal of ASCA Accreditation removes the organization from the
ASCA Pilot entirely (Refer to Section XI.G. of this guidance).
Withdrawing ASCA Recognition: cancelling an accreditation body’s full scope of ASCA
Recognition; withdrawal of ASCA Recognition removes the organization from the ASCA
Pilot entirely (Refer to Section X.F. of this guidance).

VI. Purpose of the ASCA Pilot
Evidence of conformity to one or more FDA-recognized consensus standards is often a thorough
and efficient way for a manufacturer to address certain questions of safety and/or effectiveness.

Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standardsand-conformity-assessment-program
36
Per ISO/IEC 17011
37
Per ISO/IEC 17000
38
Per ISO/IEC 17011

Contains Nonbinding Recommendations
For manufacturers and FDA to benefit from the efficiency, however, FDA must have confidence
in the DOC.39 DOCs are discussed in section 514(c)(1)(B) of the FD&C Act and FDA’s
guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices. These resources indicate that a device manufacturer may provide a DOC to
one or more FDA-recognized consensus standards in a premarket submission to be reviewed by
FDA.
A device manufacturer may declare conformity to an FDA-recognized consensus standard based
on test results; however, there may be variability in how this testing is conducted. Given this
variability, and because medical devices are increasingly complex and can involve high risks to
patients, DOCs are not always sufficient to fully address FDA’s questions regarding safety and
effectiveness for premarket submissions. As a result, FDA reviewers may need to request
additional information and review supplemental documentation as described in FDA’s guidance,
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices. In some instances, a device manufacturer may decide to repeat or revise testing based
on FDA input. These interactions and requests for modifications in test methodology can result
in delays and additional costs, but are needed to provide FDA with the necessary confidence in a
DOC for its intended purpose.
As required by FDARA40 and as part of the enactment of MDUFA IV,41 FDA committed to the
establishment of the ASCA Pilot with stakeholder input.42 FDA held a public workshop to obtain
input and recommendations from stakeholders regarding the goals, scope, procedures, and
requirements for the ASCA Pilot. The feedback sought from stakeholders (Refer to Section
VIII.A. of this guidance) was directed to the ultimate purpose of improving the efficiency of the
premarket review process by building confidence in DOCs through the use of accredited testing
laboratories.

VII. Specific Goals of the ASCA Pilot
The ASCA Pilot is intended to support FDA’s public health mission by providing increased
confidence in testing results from ASCA-accredited testing laboratories, as well as potentially
decreasing the burden of individual premarket submissions when manufacturers rely on testing
completed by ASCA-accredited testing laboratories.
The overarching goals of the ASCA Pilot are intended to:

See section 514(c)(1)(B) of the FD&C Act.
See sections 514(d)(1) and 514(d)(3)(A) of the FD&C Act
41
See also MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download
42
83 FR 2165, available at https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditationscheme-for-conformity-assessment-of-medical-devices-to-food-and-drug
40

Contains Nonbinding Recommendations
·

Enhance confidence in medical device testing
The ASCA Pilot includes application processes and periodic audits of accreditation
bodies and testing laboratories as well as the processes that will be followed for
suspension or withdrawal. These processes and audits are intended to increase confidence
in the testing performed by ASCA-accredited testing laboratories by ensuring that
ASCA-recognized accreditation bodies meet the criteria specified by FDA in this
guidance and any relevant standards-specific ASCA Pilot guidance documents
throughout their participation in the program.43 The increased confidence in testing may
be particularly helpful for premarket submissions that rely on DOC to FDA-recognized
consensus standards using test results from ASCA-accredited testing laboratories.

Promote consistency and predictability in the premarket review process
The ASCA Pilot does not introduce new requirements for medical device manufacturers.
Rather, by clearly communicating expectations for how results from ASCA-accredited
testing laboratories are included and reviewed in premarket submissions, the ASCA Pilot
intends to promote consistency and predictability in all of FDA’s premarket submission
programs.

Encourage effective use of FDA resources
The increased acceptance of DOCs under the ASCA Pilot (Refer to Section XIII. of this
guidance) allows FDA to direct scientific and regulatory resources to other priorities.

Enhance regulatory efficiency
By virtue of a testing laboratory’s ASCA Accreditation, device manufacturers can be
more confident early in the product development lifecycle that testing to the FDArecognized consensus standards and test methods within the laboratory’s scope of ASCA
Accreditation is likely to meet FDA’s regulatory requirements. FDA expects that the
application process, periodic audits, and clear communication among participants in the
ASCA Pilot will decrease the need for the FDA to request additional information
regarding testing methodologies when a premarket submission includes DOCs to a FDArecognized consensus standard eligible for inclusion in the ASCA Pilot.

Support international harmonization
FDA used elements from international conformity assessment standards in the ISO/IEC
17000 series to establish the ASCA Pilot. The standards within the ISO/IEC 17000 series
are used worldwide by stakeholders including accreditation bodies, testing laboratories,
and device manufacturers.44 In addition, most of the FDA-recognized consensus
standards and test methods selected for the ASCA Pilot are international consensus

See section 514(d)(1)(A) of the FD&C Act.
See NIST SP 2000-01 ABCs of Conformity Assessment (2018) available at
https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-01.pdf
44

Contains Nonbinding Recommendations
standards. FDA believes the experience gained in the ASCA Pilot could broadly inform
international harmonization efforts such as standards use across jurisdictions.

VIII.
A.

Development of the ASCA Pilot
Stakeholder Input

FDA has developed the framework of the ASCA Pilot with the support and participation of
stakeholders from industry, the conformity assessment community, and technical experts from
the National Institute of Standards and Technology (NIST).
In addition, FDA published a Federal Register notice45 requesting comments on a set of
questions designed to gain insight regarding the development and overall design/approach of the
ASCA Pilot including goals, pilot FDA-recognized consensus standards and test methods, design
concepts, and overall program approach. Comments received in response to this notice were
reviewed and considered in the development of this guidance. These comments were also
informative to the public meeting required by section 514(d)(3)(A).46
As required by FDARA,47 FDA held a public workshop titled “Accreditation Scheme for
Conformity Assessment of Medical Devices to Food and Drug Administration Recognized
Standards” on May 22-23, 2018,48 to discuss and obtain input and recommendations from
stakeholders about the ASCA Pilot, including its goals and scope as well as a suitable framework
and procedures to facilitate implementation. The workshop is discussed on FDA’s “Workshop
and Conferences” website.49
Input from each of these resources has been informative in the design of the conformity
assessment scheme and selection of the initial FDA-recognized consensus standards and test
methods eligible for inclusion in the ASCA Pilot as discussed in this guidance as well as the
standards-specific ASCA Pilot guidance documents.

Conformity Assessment Resources

FDA sought to maximize the use of existing frameworks and arrangements in developing the
ASCA conformity assessment scheme. This way, accreditation bodies and testing laboratories
can participate in the ASCA Pilot by leveraging existing processes and knowledge, increasing
the net benefit of participation. We also anticipate that, by using and extending existing

82 FR 22548 (May 16, 2017).
ASCA Public Workshop website: https://www.fda.gov/medical-devices/workshops-conferences-medicaldevices/public-workshop-accreditation-scheme-conformity-assessment-asca-medical-devices-fda-recognized
47
See section 514(d)(3)(A) of the FD&C Act.
48
83 FR 2165, available at https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditationscheme-for-conformity-assessment-of-medical-devices-to-food-and-drug
49
Available at https://www.fda.gov/medical-devices/news-events-medical-devices/workshops-conferences-medicaldevices
46

Contains Nonbinding Recommendations
paradigms, the lessons learned from the ASCA Pilot will be equally applicable, and therefore
beneficial, to other stakeholders (e.g., other regulatory authorities).
The conformity assessment scheme used in the ASCA Pilot leverages the following wellestablished set of international conformity assessment standards and arrangements that are used
worldwide by stakeholders including accreditation bodies, testing laboratories, and device
manufacturers:
·

International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition
Arrangement (MRA)50
ILAC is an international organization for accreditation bodies that accredit conformity
assessment bodies including testing laboratories. The accreditation bodies that are
signatories to the ILAC MRA are peer evaluated in accordance with the specifications of
ISO/IEC 17011 to demonstrate their competence. The ILAC MRA provides an
internationally recognized process used to accept accredited test reports. One
qualification for ASCA Recognition is whether the accreditation body is a signatory to the
ILAC MRA (Refer to Section X.A. of this guidance). FDA intends to leverage ILAC
MRA policies and procedures regarding accreditation body peer evaluations by reviewing
peer evaluation reports and/or participating as an observer during these activities (Refer
to Section X.E. of this guidance).

ISO/IEC 17011
This international consensus standard describes the specifications for accreditation bodies
accrediting, among others, testing laboratories. Accreditation bodies conform to ISO/IEC
17011 in order to be a signatory to the ILAC MRA, a qualification for ASCA Recognition
of an accreditation body (Refer to Section X.A. of this guidance). FDA intends to leverage
the assessments conducted by accreditation bodies per ISO/IEC 17011 by reviewing
assessment reports and/or participating as an observer during these activities (Refer to
Section X.E. of this guidance).

ISO/IEC 17025:2017: General requirements for the competence of testing and
calibration laboratories (hereafter referred to as “ISO/IEC 17025”)
This international consensus standard contains specifications for laboratories to operate
competently and generate valid results. Accreditation bodies use ISO/IEC 17025 along
with the ASCA program specifications associated with each eligible FDA-recognized
consensus standard or test method to accredit testing laboratories for the ASCA Pilot
(Refer to Section IX.A. of this guidance).

In addition to the above resources, FDA also leveraged the following NIST documents, which
provide an overview of conformity assessment, in the design, development, and implementation
50

For more information about ILAC, visit https://ilac.org/about-ilac/

Contains Nonbinding Recommendations
scheme of the ASCA Pilot as outlined in this guidance document: NIST SP 2000-01 ABCs of
Conformity Assessment (2018)51 and NIST SP 2000-02 Conformity Assessment Considerations
for Federal Agencies (2018).52

Selection of FDARecognized Consensus Standards and
Test Methods
C.

When deciding which FDA-recognized standards and test methods to include in the ASCA Pilot,
FDA sought to maximize the benefit of the ASCA Pilot to the public health by selecting FDArecognized consensus standards and test methods that manufacturers often rely upon to address
significant issues of safety and/or effectiveness. FDA identified FDA-recognized consensus
standards and test methods as eligible for the ASCA Pilot based on input from stakeholders at the
public workshop and provided in response to the Federal Register notice requesting comments.
In accordance with the MDUFA IV commitment letter,53 these standards and test methods
include both cross-cutting (horizontal) and device-specific (vertical) standards, are of public
health significance, and have or are able to provide the means for establishing acceptance.
FDA regularly considers recognition of updated editions of standards. FDA is aware that,
depending on the nature of the changes to the new edition, revisions to the associated ASCA
program specifications may be needed. For the edition of the FDA-recognized consensus
standard(s) included in the ASCA Pilot, see the FDA Recognized Consensus Standards
Database.54
As allowed under section 514(c) of the FD&C Act and further explained in FDA’s guidance
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices, manufacturers may continue to rely on other standards and provide DOC in premarket
submissions; however, other standards will not be eligible for the premarket review benefits of
the ASCA Pilot (Refer to Section XIII. of this guidance).

ASCA Program Specifications Development

ISO/IEC 17025 includes “general requirements for the competence of testing and calibration
laboratories.” Sections of the standard discuss impartiality, confidentiality, organizational
structure, resources (e.g., personnel, facilities, equipment), processes (e.g., selection and
verification of methods, validation of methods, sampling, reporting of results), and management
systems (e.g., corrective actions, control of records, management reviews). The ASCA program
specifications are used in addition to ISO/IEC 17025 by ASCA-recognized accreditation bodies
for accreditation of testing laboratories for the ASCA Pilot. In developing the ASCA program
specifications for each set of FDA-recognized consensus standards and test methods, FDA

Available at https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-01.pdf
Available at https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-02.pdf
53
See MDUFA IV Commitment Letter, pg. 14 at https://www.fda.gov/media/100848/download
54
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
52

Contains Nonbinding Recommendations
sought to ensure that the ASCA program specifications include only those aspects of testing
laboratory competence that are necessary above and beyond those already provided in ISO/IEC
17025 in order to ensure confidence in device testing submitted to FDA. FDA carefully
considered previous and current concerns with testing submitted to the FDA as well as potential
implementation challenges for accreditation bodies and testing laboratories. Stakeholder input
on the ASCA program specifications was received at a public workshop55 (Refer to Section
VIII.A. of this guidance) as well as during the guidance process.
The ASCA program specifications are located in the standards-specific ASCA Pilot guidance
documents.

IX. Roles and Responsibilities
A.

Accreditation Bodies

Under the ASCA Pilot, ASCA-recognized accreditation bodies accredit testing laboratories using
the specifications of ISO/IEC 17025 and the ASCA program specifications associated with each
eligible FDA-recognized consensus standard and test method eligible for inclusion in the ASCA
Pilot (Refer to standards-specific ASCA Pilot guidance documents). Upon granting ASCA
Recognition to an accreditation body, FDA intends to provide to the accreditation body a scope
of ASCA Recognition describing the extent to which the accreditation body has demonstrated
competence in accreditation for purposes of the ASCA Pilot. ASCA Pilot processes and policies
for accreditation bodies are described in Section X. of this guidance.
The responsibilities of an accreditation body (also referred to as “terms of participation”) are
identified in the signed agreement section of the accreditation body application (Refer to Section
D of Appendix A of this guidance).

Testing Laboratories

ASCA-accredited testing laboratories perform testing in accordance with the specifications of
ISO/IEC 17025 and ASCA program specifications associated with each eligible FDA-recognized
consensus standard and test method included in the testing laboratory’s scope of ASCA
Accreditation. A testing laboratory may work with the device manufacturer to develop a test plan
(Refer to Section XII.B. of this guidance). After testing is complete, the testing laboratory
provides the information listed in the relevant ASCA program specifications (including an
ASCA summary test report) to the device manufacturer. A testing laboratory may label its testing
as having been conducted under the ASCA Pilot only if the FDA-recognized consensus
standards and test methods used were within its scope of ASCA Accreditation at the time of
testing.

Public workshop titled “Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug
Administration-Recognized Standards” on May 22-23, 2018

Contains Nonbinding Recommendations
Upon granting ASCA Accreditation, FDA intends to provide the testing laboratory with a scope
of ASCA Accreditation describing the extent to which the testing laboratory has demonstrated
competence in testing for purposes of the ASCA Pilot. ASCA Pilot processes and policies for
testing laboratories are described in Section XI. of this guidance.
The responsibilities of a testing laboratory (also referred to as “terms of participation”) are
identified in the signed agreement section of the testing laboratory application (Refer to Section
D of Appendix B of this guidance).

Device Manufacturers

Device manufacturers may voluntarily choose to use an ASCA-accredited testing laboratory to
conduct testing to be included in premarket submissions to FDA. The device manufacturer is
responsible for including the appropriate information regarding device testing in its premarket
submission (Refer to Section XII.C. of this guidance). It is the manufacturer’s responsibility to
ensure FDA-recognized consensus standards and test methods are selected and used
appropriately and that the DOC provided in a premarket submission is consistent with the
guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices and the standards-specific ASCA Pilot guidance documents. ASCA Pilot
processes and policies for device manufacturers are described in Section XII. of this guidance.
As noted in the MDUFA IV Commitment Letter,56 a device manufacturer’s internal testing
laboratory is eligible for ASCA Accreditation. In determining whether to grant ASCA
Accreditation to a device manufacturer’s internal testing laboratory, FDA intends to consider the
same factors used in determining whether to grant ASCA Accreditation to any other testing
laboratory (Refer to Section XI.A. of this guidance). Any ASCA-accredited testing laboratory
(including a device manufacturer’s internal testing laboratory) is expected to follow the
processes and policies of this guidance and fulfill the roles and responsibilities described in
Section XI. of this guidance.

FDA Staff

FDA ASCA program staff manage the ASCA Pilot, including granting ASCA Recognition to
accreditation bodies, granting ASCA Accreditation to testing laboratories, conducting audits57 of
ASCA-recognized accreditation bodies and ASCA-accredited testing laboratories, and reviewing
information submitted by ASCA-recognized accreditation bodies and ASCA-accredited testing
laboratories per their terms of participation. FDA ASCA program staff are also responsible for
the ASCA website, which provides an up-to-date listing of ASCA-recognized accreditation
bodies (including the scopes of and expiration dates for ASCA Recognition) and ASCAaccredited testing laboratories (including the scopes of and expiration dates for ASCA
56

See MDUFA IV Commitment Letter pg. 14: https://www.fda.gov/media/100848/download
Per NIST SP 2000-01 ABCs of Conformity Assessment (2018): “Audit activities use an organized, predictable
process for assessing records and other information to determine whether requirements have been fulfilled.” FDA
staff’s audits will determine whether the processes and policies of this guidance document have been fulfilled.
57

Contains Nonbinding Recommendations
Accreditation). FDA ASCA program staff are responsible for ensuring consistent
implementation of the processes and policies in this guidance document and providing any
training to ASCA Pilot participants necessary to (a) maintain FDA’s confidence in the testing
submitted by ASCA-accredited testing laboratories and to (b) ensure that ASCA-recognized
accreditation bodies meet the criteria specified by FDA for participation in the ASCA Pilot and
continue to satisfy those criteria throughout their participation in the program. 58 ASCA Pilot
processes and policies for management of the ASCA Pilot are described in Sections X. and XI.
of this guidance.
FDA review staff conduct reviews of premarket submissions in accordance with existing
statutes, regulations, and guidance. When premarket submissions include testing from an
ASCA-accredited testing laboratory, FDA review staff are responsible for applying the statute,
section 514(d) of the FD&C Act, and the policies described in this guidance. ASCA Pilot
processes and policies regarding review of testing from an ASCA-accredited testing laboratory
are described in Section XIII. of this guidance.
The FDA ASCA program staff managing the ASCA Pilot are separate and independent from the
FDA review staff conducting premarket reviews.

Processes and Policies for Accreditation Bodies
A.

Qualifications for ASCA Recognition

FDA will consider the following factors in determining whether to grant ASCA Recognition to an
accreditation body :

1. Does the accreditation body have a scope of ‘signatory status’ of
Testing: ISO/IEC 17025 to the International Laboratory
Accreditation Cooperation (ILAC) Mutual Recognition
Arrangement (MRA)?
This factor relies on the well-established set of international standards and arrangements for
conducting conformity assessment activities (Refer to Section VIII.B. of this guidance).
Signatories to the ILAC MRA are peer-reviewed by other ILAC signatories for competence in
accrediting conformity assessment bodies, which provides confidence that testing laboratories
accredited by ILAC signatories are competent in their implementation of ISO/IEC 17025 and the
ASCA program specifications associated with each eligible FDA-recognized consensus standard
and test method.

2. Is the accreditation body based in the United States?
Many accreditation bodies exist within and outside of the United States to support global
conformity assessment activities. By limiting the ASCA Pilot to accreditation bodies based in the

See section 514(d)(1)(A) of the FD&C Act.

Contains Nonbinding Recommendations
United States, FDA aims to effectively use limited resources to facilitate successful program
implementation during the pilot.

3. Has the accreditation body agreed in writing to the terms of
participation described in Section D of Appendix A of this guidance?
The terms and conditions outlined in Section D of Appendix A of this guidance are designed to
ensure transparency and accountability on the part of the accreditation body in all aspects of its
participation in the ASCA Pilot. An accreditation body may choose not to follow the terms of
participation at any time; however, ASCA Recognition is contingent upon following such terms.

Accreditation Body Application Process

An accreditation body may apply for ASCA Recognition by submitting, via email to
ASCA@fda.hhs.gov, documentation demonstrating how the applicant organization addresses the
qualifications specified in Section X.A. of this guidance. Appendix A of this guidance provides
more information on application contents for accreditation bodies. FDA intends to acknowledge
receipt of the application and provide a unique ASCA Accreditation Body Identification Number
to the accreditation body and a unique submission number used solely for tracking the
application.
FDA intends to review applications for ASCA Recognition within 60 calendar days. After
reviewing application contents, FDA intends to notify the accreditation body via email of the
issues, if any, that may preclude ASCA Recognition so that any issues may be addressed (if
possible). When review is complete, FDA intends to inform the accreditation body via email of
our decision. If ASCA Recognition is granted, FDA will provide a scope of and expiration date
(e.g., two years) for ASCA Recognition. Note that the scope will include only FDA-recognized
consensus standards and test methods in the ASCA Pilot for which competence has been
demonstrated. When FDA grants ASCA Recognition to an accreditation body, it will update the
ASCA website to list the organization along with its scope of and expiration date for ASCA
Recognition.
FDA’s decision to grant ASCA Recognition to an accreditation body is discretionary. FDA may
decide not to grant ASCA Recognition to an accreditation body, e.g., for reasons of public health
or administrative efficiency. If FDA does not grant ASCA Recognition to an accreditation body,
FDA intends to provide a rationale for the decision to the applicant.
Up to six months prior to the expiration of its ASCA Recognition, an accreditation body may
apply to renew its ASCA Recognition following the same process outlined above.

Extension of ASCA Recognition

FDA understands that accreditation bodies may continually add capabilities to their programs
and increase their internal expertise. FDA encourages accreditation bodies to extend their ASCA
Recognition by adding FDA-recognized consensus standards and test methods to their scope of
ASCA Recognition when additional competencies are attained. For example, an accreditation
body may initially participate in the ASCA Pilot by accrediting testing laboratories for MEM
18

Contains Nonbinding Recommendations
Elution Cytotoxicity testing. After some time, the accreditation body may obtain additional
resources that can also support accrediting testing laboratories for Complement Activation
testing. The accreditation body may then apply to extend its ASCA Recognition by adding
Complement Activation testing to its scope of ASCA Recognition. In such a situation, the FDArecognized consensus standards and test methods eligible for inclusion in the ASCA Pilot would
not change, only the FDA-recognized consensus standards and test methods in the individual
accreditation body’s scope of ASCA Recognition.
An accreditation body may apply to extend its ASCA Recognition by following the same
procedures used for its initial application for ASCA Recognition. That is, an accreditation body
may submit documentation indicating how it meets the qualifications specified in Section X.A.
of this guidance with respect to the additional FDA-recognized consensus standards or test
methods via email to ASCA@fda.hhs.gov. Recommended application contents are described in
Appendix A of this guidance. In addition to the contents outlined in this appendix, FDA
recommends that the application include the following:
·
·
·

the ASCA Accreditation Body Identification Number for the accreditation body;
the current scope of ASCA Recognition for the accreditation body; and
the FDA-recognized consensus standards or test methods that the accreditation body
requests be added to its scope of ASCA Recognition.

FDA intends to use the same ASCA Accreditation Body Identification Number to track all
activity for a given accreditation body, including extensions to ASCA Recognition.
FDA intends to update the scope of ASCA Recognition of each accreditation body on the ASCA
website as appropriate.

Requests for Clarification

A Request for Clarification is a request submitted to FDA for clarification of one or more
specific ASCA program specifications from an ASCA-recognized accreditation body. A Request
for Clarification presents a question relative to implementation of ASCA program specifications.
It does not include suggestions or requests for modifications to the ASCA Pilot or hypothetical
issues.
A Request for Clarification may be submitted to ASCA@fda.hhs.gov.

Contains Nonbinding Recommendations

Audits of Accreditation Bodies

FDA intends to periodically audit accreditation bodies to ensure that they are adequately
fulfilling program expectations. 59 FDA intends to use a tiered-approach with three levels of
audits.
As an ILAC MRA signatory, an accreditation body must agree to maintain conformance to
ISO/IEC 17011 and agrees to periodic monitoring that includes re-evaluations conducted every
four years, although shorter intervals can be determined by ILAC if needed.60 For Level 1 audits
of an accreditation body, FDA intends to leverage the existing arrangement of ILAC evaluations
by requesting a copy of the most recent re-evaluation report. Upon review of the report, FDA
may request clarification or additional information. FDA intends to follow the established 4-year
schedule of the ILAC MRA. FDA may request a copy of the most recent evaluation report if the
next peer evaluation is scheduled after the currently identified sunset of the ASCA Pilot. 61
For Level 2 audits of the accreditation body, FDA intends to participate as an observer during the
next scheduled ILAC peer re-evaluation and request a copy of the re-evaluation report for
review. FDA will notify an accreditation body of the intent to participate and make the
appropriate arrangements for an on-site visit. FDA intends to use Level 2 audits if there is a
reason to believe Level 1 audits would be insufficient. Reasons to conduct a Level 2 audit could
include, but are not limited to, observing persistent issues with testing laboratories accredited by
a particular accreditation body, observing a trend upon review of the testing laboratory and/or
accreditation body complaint logs, or if Level 1 audits of the accreditation body do not
adequately address issues concerning participation in the ASCA Pilot.
For Level 3 audits, FDA intends to initiate an on-site or remote audit of an accreditation body.
This audit will not follow the ILAC MRA peer-evaluation schedule. FDA will work with the
accreditation body to make the appropriate arrangements for an FDA-initiated audit. Reasons to
conduct a Level 3 audit could include, but are not limited to if there is a public health concern
regarding the safety of a device or when Level 1 and Level 2 audits do not adequately address
issues concerning participation in the ASCA Pilot by the accreditation body.
Note that FDA may request additional information from an accreditation body as a result of any
of the audits discussed above.
Failure to comply with the policies and processes outlined in this guidance and other related
standards-specific ASCA Pilot guidances can lead to withdrawal of an accreditation body’s
ASCA Recognition as described in Section X.F. of this guidance.

See section 514(d)(2)(A) of the FD&C Act.
See https://ilac.org/ilac-membership/membership-criteria/ for information on membership criteria for ILAC MRA
Signatories.
61
See section 514(d)(4) of the FD&C Act.
60

Contains Nonbinding Recommendations

Withdrawal of ASCA Recognition

One purpose of the ASCA Pilot is to increase FDA’s confidence in testing results and DOCs
provided in premarket submissions. In certain circumstances, and as authorized in section
514(d)(2) of the FD&C Act, FDA may withdraw an accreditation body’s ASCA Recognition to
maintain confidence in the results submitted under the ASCA Pilot. Withdrawal of ASCA
Recognition cancels the accreditation body’s full scope of ASCA Recognition and removes the
organization from the ASCA Pilot entirely.

1. Considerations for Withdrawal
FDA may identify issues, using a variety of mechanisms, that raise concerns regarding an
accreditation body’s ability to adequately fulfill its role in the ASCA Pilot. As explained in
Section D of Appendix A of this guidance, the signed agreement included in an accreditation
body application for ASCA Recognition contains an agreement to permit FDA to observe and
assess ASCA-related activities. A complete accreditation body application also includes an
agreement to provide reports and notification of any changes that may impact the organization’s
participation in the ASCA Pilot. FDA may also obtain information about the competence of an
accreditation body and its adherence to the criteria specified by FDA for participation in the
ASCA Pilot when it reviews and compares a testing laboratory’s requested scope of ASCA
Accreditation to the scope of accreditation provided by the accreditation body.
Withdrawal of ASCA Recognition may be an appropriate measure when the findings from the
periodic audits of an accreditation body suggest unreliable accreditation activities or when FDA
becomes aware of information materially bearing on safety or effectiveness of a device for which
the premarket submissions included testing from an ASCA-accredited testing laboratory that was
accredited by the accreditation body (Refer to Section XIII.A. of this guidance).
The examples below describe additional issues that might decrease FDA’s confidence in an
accreditation body and, therefore, result in withdrawal of its ASCA Recognition. This list is not
intended to be exhaustive.
·

Violation of law or violation of policies outlined in this guidance or other standardsspecific ASCA Pilot guidances.
FDA’s confidence in the ASCA Pilot relies on the integrity of ASCA-recognized
accreditation bodies. FDA may consider withdrawing ASCA Recognition if, based on
credible evidence, the organization likely committed or participated in a violation of law
or a violation of the policies outlined in this or any standards-specific ASCA Pilot
guidance document. For example, FDA may withdraw an accreditation body’s ASCA
Recognition if it labels accreditation activities conducted outside of its scope of ASCA
Recognition as having been conducted under the ASCA Pilot.

Failure to correct nonconformity.
If an ASCA-recognized accreditation body fails to satisfactorily correct a nonconformity
after notification(s), FDA may withdraw the organization’s ASCA Recognition depending

Contains Nonbinding Recommendations
on the nature of the nonconformity. For example, FDA may withdraw ASCA Recognition
if, after FDA notification, the organization continually fails to address nonconformities.
·

Failure to adhere to signed agreement.
The application for ASCA Recognition includes several items that accreditation bodies
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of
Appendix A). For example, an accreditation body agrees to notify FDA of specific
changes relative to the testing laboratories it has accredited for the ASCA Pilot. If an
accreditation body repeatedly fails to provide appropriate notifications to FDA, this may
result in withdrawal of the organization’s ASCA Recognition.

Information materially bearing on safety or effectiveness of a device for which the
premarket submission included testing from an ASCA-accredited testing laboratory that
was accredited by the accreditation body.62
FDA may obtain information about safety and effectiveness of a device that reasonably
relates to the laboratory that tested the device and, by association, the accreditation body
that accredited the testing laboratory. For example, a device performance issue may
reveal that an ASCA-accredited testing laboratory failed to execute the device
manufacturer’s test plan correctly. A testing laboratory’s repeated failure to correctly
execute test plans could raise concerns with the competence of the accreditation body
providing its accreditation; these concerns, especially if observed in multiple testing
laboratories accredited by the same accreditation body, may result in withdrawal of the
accreditation body’s ASCA Recognition.

Withdrawal or suspension of ASCA Accreditation for a testing laboratory that was
accredited by the accreditation body.
FDA relies on ASCA-recognized accreditation bodies to accredit testing laboratories for
the ASCA Pilot. If ASCA Accreditation of a testing laboratory is suspended or
withdrawn, FDA may consider withdrawing the ASCA Recognition of the accreditation
body that accredited that testing laboratory for the ASCA Pilot. FDA will carefully
consider the reasons for suspension or withdrawal of ASCA Accreditation from a testing
laboratory when determining whether and what action (e.g., withdrawal of ASCA
Recognition) to take with the associated accreditation body. FDA intends to notify
accreditation bodies when ASCA Accreditation is suspended or withdrawn from testing
laboratories they have accredited (Refer to Section XI.F.3. and XI.G.3. of this guidance).

As with the initial decision to grant ASCA Recognition to an accreditation body, the decision to
withdraw ASCA Recognition is discretionary. FDA may decide to withdraw ASCA Recognition
for other reasons not listed above.

See section 514(d)(2)(B) of the FD&C Act.

Contains Nonbinding Recommendations

2. Implications for ASCA activities
Withdrawal of an accreditation body’s ASCA Recognition removes the accreditation body from
the ASCA Pilot. Any activities performed after withdrawal of ASCA Recognition should not be
identified as being performed as part of the ASCA Pilot.
Withdrawal of an accreditation body’s ASCA Recognition may affect the testing laboratories it
accredited for the ASCA Pilot (Refer to Section XI.F.1. and XI.G.1. of this guidance). As
described in Section XIII.B. of this guidance, withdrawal of an accreditation body’s ASCA
Recognition affects FDA premarket review only indirectly in that the withdrawal may result in
suspending or withdrawing the associated testing laboratory’s ASCA Accreditation.

3. Procedures
When an accreditation body’s ASCA Recognition is withdrawn (and the organization is,
therefore, removed from the ASCA Pilot), FDA intends to send a withdrawal letter via email to
the contact on record for the accreditation body. The letter will include the reason for the
withdrawal and, if appropriate, how the issues identified may be addressed in a future, new
application for ASCA Recognition.
An accreditation body may voluntarily request to withdraw its ASCA Recognition by submitting
an email to ASCA@fda.hhs.gov. To facilitate processing, FDA recommends that an
accreditation body’s request to withdraw its ASCA Recognition include the ASCA Accreditation
Body Identification Number. FDA intends to confirm the withdrawal with the contact on record
within 14 calendar days of receipt of a request for voluntary withdrawal.
Upon withdrawal of an accreditation body’s ASCA Recognition, FDA will update the ASCA
website as appropriate and notify all ASCA-accredited testing laboratories who received their
accreditation from the affected accreditation body. Considerations for the ASCA-accredited
testing laboratories are discussed in Section XI.F.1. and XI.G.1. of this guidance.
If an accreditation body wishes to participate in the ASCA Pilot after withdrawal of its ASCA
Recognition, the organization should submit a new application for ASCA Recognition following
the same procedures for an initial application as outlined in this guidance. FDA recommends that
the new application include the ASCA Accreditation Body Identification Number and indicate
whether the withdrawal was voluntary. If withdrawal was not voluntary, FDA recommends the
response include reference to FDA’s letter and explain how all issues identified in the
withdrawal letter were addressed.

XI. Processes and Policies for Testing Laboratories
A.

Qualifications for ASCA Accreditation

FDA intends to consider the following factors in determining whether to grant ASCA
Accreditation to a testing laboratory:

Contains Nonbinding Recommendations

1. Is the testing laboratory’s requested scope of ASCA Accreditation
consistent with the scope of accreditation provided by an ASCArecognized accreditation body?
This factor relies on the process for granting ASCA Recognition to accreditation bodies and
ensures that the testing laboratory is appropriately accredited. Accreditation by an ASCArecognized accreditation body to FDA-recognized consensus standards and test methods
included in the ASCA Pilot provides confidence in the testing laboratory because FDA has
determined the accreditation body is competent for the purposes of the ASCA Pilot with respect
to the eligible FDA-recognized consensus standards and test methods. FDA’s review of the
testing laboratory’s requested scope of ASCA Accreditation and its comparison to the scope of
accreditation provided by an ASCA-recognized accreditation body permits FDA to ensure that
an ASCA-accredited testing laboratory has met, and continues to meet, the criteria specified by
FDA for participation in the ASCA Pilot.63

2. Has the testing laboratory agreed in writing to the terms of
participation described in Section D of Appendix B of this guidance?
The terms and conditions outlined in Section D of Appendix B of this guidance are designed to
ensure transparency and accountability on the part of the testing laboratory in all aspects of its
participation in the ASCA Pilot. A testing laboratory may choose not to follow the terms of
participation at any time; however, ASCA Accreditation is contingent upon following such terms.

Testing Laboratory Application Process

A testing laboratory may apply for ASCA Accreditation by submitting, via email to
ASCA@fda.hhs.gov, documentation demonstrating how they address the qualifications specified
in Section XI.A. of this guidance. Appendix B of this guidance provides more information on
application contents for testing laboratories. FDA intends to acknowledge receipt of the
application and provide a unique ASCA Testing Laboratory Identification Number to the testing
laboratory and a unique submission number used solely for tracking the application.
FDA intends to review applications for ASCA Accreditation within 60 calendar days. After
reviewing application contents, FDA intends to notify the testing laboratory via email of the
issues, if any, that may preclude granting ASCA Accreditation so that any issues may be
addressed (if possible). When review is complete, FDA intends to inform the testing laboratory
via email of our decision. If ASCA Accreditation is granted, FDA will provide a scope of and
expiration date (e.g., two years) for ASCA Accreditation. Note that the scope will include only
FDA-recognized consensus standards and test methods in the ASCA Pilot for which competence
in testing has been demonstrated. When FDA grants ASCA Accreditation to a testing laboratory,
it will update the ASCA website to list the organization along with its scope of and expiration
date for ASCA Accreditation.

See section 514(d)(1)(A) of the FD&C Act.

Contains Nonbinding Recommendations
FDA’s decision to grant ASCA Accreditation to a testing laboratory is discretionary. FDA may
decide not to grant ASCA Accreditation to a testing laboratory, e.g., for reasons of public health
or administrative efficiency. If FDA does not grant ASCA Accreditation to a testing laboratory,
FDA intends to provide a rationale for the decision to the applicant.
Up to six months prior to expiration of its ASCA Accreditation, a testing laboratory may apply to
renew its ASCA Accreditation following the same process outlined above.

Extension of ASCA Accreditation

FDA understands that testing laboratories may continually add capabilities to their programs and
increase their internal expertise. FDA encourages testing laboratories to extend their ASCA
Accreditation by adding FDA-recognized consensus standards and test methods to their scope of
ASCA Accreditation when additional competencies are attained. For example, a testing
laboratory may initially participate in the ASCA Pilot by conducting MEM Elution Cytotoxicity
testing. After some time, the testing laboratory may obtain additional equipment and resources
that can also support Complement Activation testing. The testing laboratory may then apply to
extend its ASCA Accreditation by adding Complement Activation testing to its scope of ASCA
Accreditation. In such a situation, the FDA-recognized consensus standards and test methods
eligible for inclusion in the ASCA Pilot would not change, only the FDA-recognized consensus
standards and test methods in the individual testing laboratory’s scope of ASCA Accreditation.
A testing laboratory may apply to extend its ASCA Accreditation by following the same
procedures used for its initial application. That is, a testing laboratory may submit documentation
indicating how it meets the qualifications specified in Section XI.A. of this guidance with respect
to the additional FDA-recognized consensus standards or test methods via email to
ASCA@fda.hhs.gov. Recommended application contents are described in Appendix B of this
guidance. In addition to the contents outlined in this appendix, FDA recommends that the
application include the following:
·
·
·

the ASCA Testing Laboratory Identification Number of the testing laboratory;
the current scope of ASCA Accreditation for the testing laboratory; and
the FDA-recognized consensus standards or test methods that the testing laboratory
requests be added to its scope of ASCA Accreditation.

FDA intends to use the same ASCA Testing Laboratory Identification Number to track all
activity for a given testing laboratory, including extensions to ASCA Accreditation.
FDA intends to update the scope of ASCA Accreditation on the ASCA website as appropriate.

Requests for Clarification

A Request for Clarification is a request submitted to FDA for clarification of one or more
specific ASCA program specifications from an ASCA-accredited testing laboratory. A Request
for Clarification presents a question relative to implementation of ASCA program specifications.
It does not include suggestions or requests for modifications to the ASCA Pilot or hypothetical
issues.
25

Contains Nonbinding Recommendations
A Request for Clarification may be submitted to ASCA@fda.hhs.gov.

Audits of Testing Laboratories

FDA intends to periodically audit testing laboratories to ensure that they are adequately fulfilling
program expectations.64 FDA intends to use a tiered-approach with three levels of audits.
In order to maintain conformance with ISO/IEC 17011, an accreditation body assesses its
accredited testing laboratories at least every 2 years. 65 For Level 1 audits of the testing
laboratory, FDA intends to leverage the existing arrangement of assessments between
accreditation bodies and testing laboratories by requesting a copy of the most recent assessment
report of the testing laboratory. Upon review of the report, FDA may request clarification or
additional information. FDA intends to follow the established schedule of accreditation body
assessments of the testing laboratory.
For Level 2 audits of the testing laboratories, FDA intends to participate as an observer during
the next scheduled assessment of the testing laboratory by the accreditation body and request a
copy of the report for review. FDA will notify the accreditation body and testing laboratory of
the intent to participate and make the appropriate arrangements for an on-site visit. FDA intends
to use Level 2 audits if there is a reason to believe Level 1 audits would be insufficient. Reasons
to use a Level 2 audit could include, but are not limited to, observing persistent issues with a
testing laboratory, observing a trend upon review of the testing laboratory complaint logs, if
Level 1 audits of the testing laboratory do not adequately address issues concerning participation
in the ASCA Pilot.
For Level 3 audits, FDA intends to initiate an on-site or remote audit of the testing laboratory.
This audit will not follow the assessment schedule established by the accreditation body. FDA
will work directly with the testing laboratory to make the appropriate arrangements for an FDAinitiated audit. Level 3 audits will typically be used for only issues of highest concern such as
when Level 1 and Level 2 audits do not adequately address issues concerning participation in the
ASCA Pilot Program. FDA will notify the appropriate accreditation body of the intent to initiate
on-site or remote audit of the testing laboratory.
Note that FDA may request additional information from the testing laboratory as a result of any
of the audits discussed above.
Failure to comply with the policies and processes outlined in this guidance and any other related
ASCA program guidance can lead to changes to a testing laboratory’s ASCA Accreditation as
described in Section XI.F. and XI.G. of this guidance.

See section 514(d)(2)(A) of the FD&C Act .
See 7.9.3 of ISO/IEC 17011: Conformity assessment – Requirements for accreditation bodies accrediting
conformity assessment bodies.
65

Contains Nonbinding Recommendations

Suspension of ASCA Accreditation

Section 514(d)(2) of the FD&C Act provides that FDA may suspend a testing laboratory’s
ASCA Accreditation. Suspension puts temporary constraints on one or more FDA-recognized
consensus standards or test methods in a testing laboratory’s scope of ASCA Accreditation while
the issues resulting in the suspension are addressed.

1. Considerations for Suspension
FDA may identify issues, using a variety of mechanisms, that raise potential concerns regarding
a testing laboratory’s ability to adequately fulfill its role in the ASCA Pilot. As explained in
Section D of Appendix B of this guidance, the signed agreement included in a testing laboratory
application for ASCA Accreditation contains an agreement to permit FDA to observe and assess
ASCA-related activities. A complete testing laboratory application also includes an agreement to
provide reports and notification of any changes that may impact the organization’s participation
in the ASCA Pilot. FDA may also obtain information about the competence of a testing
laboratory when it reviews information from the accreditation body or testing results from the
testing laboratory included in premarket submissions.
Suspending ASCA Accreditation may be an appropriate measure when the findings from the
periodic audits of the testing laboratories suggest that testing results may be unreliable or when
FDA becomes aware of information materially bearing on safety or effectiveness of a device for
which the premarket submissions included testing from the ASCA-accredited testing laboratory
(Refer to Section XIII.A. of this guidance). The suspension allows FDA to maintain confidence in
the ASCA Pilot while adapting to the needs and abilities of ASCA-accredited testing
laboratories.
When determining whether to suspend a testing laboratory’s ASCA Accreditation, FDA considers
whether the issues identified are of a magnitude for which a temporary constraint can adequately
maintain confidence in the ASCA Pilot. Suspending a testing laboratory’s ASCA Accreditation is
used when confidence in the ASCA Pilot can be maintained by constraining the testing
laboratory to label its testing as having been conducted during a period of suspension (e.g.,
temporary loss and then repair of specific test-related resources). By labeling its testing as having
been conducted during a period of suspension, the testing laboratory clearly communicates to the
device manufacturer, who then communicates to FDA via the premarket submission, that FDA
may need to conduct additional review of the results (Refer to Section XIII.B. of this guidance).
This clear communication about the status of the testing laboratory during testing maintains
confidence in the ASCA Pilot.
FDA will only put a temporary constraint on the FDA-recognized consensus standards and test
methods within a testing laboratory’s scope of ASCA Accreditation that are impacted by the
issues resulting in suspension.
FDA may consider withdrawing the testing laboratory’s ASCA Accreditation if the issues
identified are of a magnitude for which constraining the testing laboratory to label the testing as
having been conducted during a period of suspension is inadequate to maintain confidence in the

Contains Nonbinding Recommendations
ASCA Pilot (e.g., repeated failure to correct nonconformities or follow policies and procedures
of this guidance) (Refer to Section XI.G. of this guidance).
The examples below describe situations in which FDA might suspend a testing laboratory’s
ASCA Accreditation. This list is not intended to be exhaustive.
·

Existence of nonconformity.
Depending on the nature of the nonconformity identified, FDA may determine that a
testing laboratory needs to label its testing as having been conducted during a period of
suspension until the nonconformity is adequately addressed. The labeling constraint
would apply only to testing conducted using the FDA-recognized consensus standards
and test methods affected by the nonconformity.

Inadequate completion of training or communication with FDA.
The application for ASCA Accreditation includes several items that testing laboratories
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of
Appendix B). For example, a testing laboratory agrees to attend FDA training and
communicate with FDA. If a testing laboratory fails to complete training or submit
information to FDA, FDA may suspend its ASCA Accreditation until such training is
completed or information is submitted. Depending on the nature of the incomplete
training or unsubmitted information, FDA may choose to constrain labeling of testing to
one or more of the FDA-recognized consensus standards and test methods within the
testing laboratory’s scope of ASCA Accreditation.

Information materially bearing on safety or effectiveness of a device for which a
premarket submission included testing from the testing laboratory.66
FDA may become aware of information materially bearing on study conduct or quality
for which labeling of testing results as having been conducted during a period of
suspension is necessary to maintain confidence in the ASCA Pilot. For example, if an
ASCA-accredited testing laboratory under the purview of 21 CFR 58 receives from the
FDA Bioresearch Monitoring Program a warning letter including issues that impact its
testing under the ASCA Pilot, FDA may suspend that testing laboratory’s ASCA
Accreditation until the issues are addressed. During the period of suspension (e.g., until
the warning letter is adequately addressed), the testing laboratory would label the affected
testing results as having been conducted during a period of suspension.

See section 514(d)(2)(B) of the FD&C Act.

Contains Nonbinding Recommendations
withdrawn from the ASCA Pilot, FDA may suspend (or withdraw) a testing laboratory’s
ASCA Accreditation while the testing laboratory seeks accreditation from an alternative
ASCA-recognized accreditation body. FDA will carefully consider the reasons for
withdrawal of ASCA Recognition from the accreditation body when determining whether
and what action (e.g., suspension or withdrawal of ASCA Accreditation) to take regarding
the associated testing laboratories. Note that FDA intends to notify affected testing
laboratories if their accreditation body’s ASCA Recognition is withdrawn (Refer to
Section X.F.3. of this guidance).
As with the initial decision to grant ASCA Accreditation to a testing laboratory, the decision to
suspend ASCA Accreditation is discretionary. FDA may decide to suspend ASCA Accreditation
for other reasons not listed above.

2. Implications for ASCA activities
When a testing laboratory’s ASCA Accreditation is suspended, temporary constraints are put on
how it may label its testing relative to the ASCA Pilot. FDA will indicate to the testing
laboratory the FDA-recognized consensus standards and test methods within the organization’s
scope of ASCA Accreditation for which testing (including the ASCA summary test report) should
be labeled as having been conducted during a period of suspension.
A device manufacturer indicates in their DOC whether the FDA-recognized consensus standards
and test methods used by the testing laboratory were impacted by suspension of the testing
laboratory's ASCA Accreditation (Refer to Section XIII.C.2. of this guidance). Premarket review
considerations for testing conducted during a period of suspension are provided in Section
XIII.B. of this guidance.
While ASCA Accreditation is suspended, FDA expects that the testing laboratory will continue to
adhere to the signed agreement (Refer to Section D of Appendix B of this guidance) as well as the
policies and processes of this guidance and any other relevant standards-specific ASCA Pilot
guidance documents.
Suspension of a testing laboratory’s ASCA Accreditation may affect the accreditation body that
accredited it for the ASCA Pilot, depending on the reasons for suspension (Refer to Section
X.F.1. of this guidance). At a minimum, FDA will likely discuss with the accreditation body the
reasons for suspension as well as any plans for resolution. If FDA suspends a testing laboratory’s
ASCA Accreditation, an accreditation body’s own decision regarding that laboratory is not
necessarily affected. An accreditation body may continue to accredit the testing laboratory;
however, FDA would no longer recognize that accreditation for purposes of the ASCA Pilot.

3. Procedures
a. Initiating Suspension
When FDA suspends a testing laboratory’s ASCA Accreditation, we intend to send a letter via
email to the contact on record for the testing laboratory. The letter will include the FDArecognized consensus standards or test methods for which testing (including ASCA summary test

Contains Nonbinding Recommendations
reports) should be labeled as having been conducted during a period of suspension and how the
issues resulting in suspension may be addressed.
A testing laboratory may also voluntarily request that its ASCA Accreditation be suspended. Such
a request should be submitted to ASCA@fda.hhs.gov and include the following information.
·
·
·
·

the issues resulting in suspension of ASCA Accreditation;
the planned timeline and/or actions to address the issues resulting in ASCA Accreditation;
the FDA-recognized consensus standards and test methods for which the temporary
labeling constraint applies; and
the testing laboratory’s ASCA Testing Laboratory Identification Number.

FDA intends to confirm requests to voluntarily suspend ASCA Accreditation with the contact on
record within 14 calendar days of receipt of a request.
Upon suspension of a testing laboratory’s ASCA Accreditation, FDA will update the ASCA
website to reflect the temporary constraint on the impacted FDA-recognized consensus standards
and test methods within the testing laboratory’s scope of ASCA Accreditation. FDA will also
notify the accreditation body that accredited that testing laboratory. Considerations for the
accreditation body are discussed in Section X.F.1. of this guidance.
b. Lifting Suspension
To lift a suspension of ASCA Accreditation, a testing laboratory should send a response to
ASCA@fda.hhs.gov documenting how all issues resulting in suspension were resolved. To
facilitate processing, FDA recommends that the response include the ASCA Testing Laboratory
Identification Number and indicate whether the suspension was voluntary. If suspension was not
voluntary, FDA recommends the response include reference to FDA’s suspension letter.
Once the issues that resulted in suspension have been adequately addressed to FDA’s
satisfaction, the agency intends to send a letter via email to the contact on record indicating that
the testing laboratory’s ASCA Accreditation is no longer suspended and the temporary
constraints have been lifted. FDA will update the ASCA website to ensure that it accurately
reflects the scope of ASCA Accreditation.

Withdrawal of ASCA Accreditation

Section 514(d)(2) of the FD&C Act provides that FDA may withdraw a testing laboratory’s
ASCA Accreditation. Withdrawal of ASCA Accreditation cancels the testing laboratory’s full
scope of ASCA Accreditation and removes the organization from the ASCA Pilot entirely.

1. Considerations for Withdrawal
FDA may identify issues, using a variety of mechanisms, that raise concerns regarding a testing
laboratory’s ability to adequately fulfill its role in the ASCA Pilot. As explained in Section D of
Appendix B of this guidance, the signed agreement included in a testing laboratory’s application
for ASCA Accreditation contains an agreement to permit FDA to observe and assess ASCA-

Contains Nonbinding Recommendations
related activities. A complete testing laboratory application also includes an agreement to
provide reports and notification of any changes that may impact the organization’s participation
in the ASCA Pilot. FDA may also obtain information about the competence of a testing
laboratory when it reviews information from the accreditation body or testing results from the
testing laboratory included in premarket submissions.
Withdrawal of a testing laboratory’s ASCA Accreditation may be an appropriate measure
depending on the findings from periodic audits of testing laboratories or when FDA becomes
aware of information materially bearing on safety or effectiveness of a device for which a
premarket submission included testing from an ASCA-accredited testing laboratory (Refer to
Section XIII.A. of this guidance).
When determining whether to withdraw a testing laboratory’s ASCA Accreditation, FDA intends
to consider whether the issues identified are of a magnitude for which a temporary constraint
cannot adequately maintain confidence in the ASCA Pilot. Withdrawal of a testing laboratory’s
ASCA Accreditation is used when confidence in the ASCA Pilot cannot be maintained by
constraining the testing laboratory to label its testing as having been conducted during a period
of suspension (e.g., repeated failure to correct nonconformities or follow policies and procedures
of this guidance).
The examples below describe situations in which FDA may consider withdrawing a testing
laboratory’s ASCA Accreditation. This list is not intended to be exhaustive.
·

Violation of law or violation of policies outlined in this guidance and other standardsspecific ASCA Pilot guidances.
FDA’s confidence in the ASCA Pilot relies on the integrity of ASCA-accredited testing
laboratories. FDA may consider withdrawing a testing laboratory’s ASCA Accreditation
if, based on credible evidence, the organization likely committed or participated in a
violation of law or a violation of the policies outlined in this or any standards-specific
ASCA Pilot guidance document. For example, FDA may withdraw a testing laboratory’s
ASCA Accreditation, thereby removing it from the ASCA Pilot, if it labels testing results
conducted outside of its scope as having been conducted under the ASCA Pilot.

Failure to correct nonconformity.
If an ASCA-accredited testing laboratory fails to satisfactorily correct a nonconformity
after notification(s) by either their accreditation body or FDA, FDA may consider
withdrawing its ASCA Accreditation depending on the nature of the nonconformity.

Failure to adhere to signed agreement.
The application for ASCA Accreditation includes several items that testing laboratories
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of
Appendix B). For example, a testing laboratory agrees to notify FDA of changes that may
affect its participation in the ASCA Pilot. If a testing laboratory repeatedly fails to

Contains Nonbinding Recommendations
provides appropriate notifications to FDA, this may result in withdrawal of the
organization’s ASCA Accreditation.
·

Information materially bearing on safety or effectiveness of a device for which a
premarket submission included testing from the testing laboratory.67
FDA may become aware of information materially bearing on study conduct or quality.
For example, if an ASCA-accredited testing laboratory under the purview of 21 CFR 58
receives from the FDA Bioresearch Monitoring Program a warning letter including issues
that impact its testing under the ASCA Pilot and fails to correct such issues, FDA may
withdraw that testing laboratory’s ASCA Accreditation.

Withdrawal of ASCA Recognition from the accreditation body that accredited the testing
laboratory for the ASCA Pilot.
FDA relies on ASCA-recognized accreditation bodies to accredit testing laboratories for
the ASCA Pilot. If the accreditation body that accredited a testing laboratory is
withdrawn from the ASCA Pilot, FDA may withdraw (or suspend) a testing laboratory’s
ASCA Accreditation while the testing laboratory seeks accreditation from an alternative
ASCA-recognized accreditation body. FDA will carefully consider the reasons for
withdrawal of ASCA Recognition from the accreditation body when determining whether
and what action (e.g., withdrawal of suspension of ASCA Accreditation) to take regarding
the associated testing laboratories. Note that FDA intends to notify affected testing
laboratories if their accreditation body’s ASCA Recognition is withdrawn (Refer to
Section X.F.3. of this guidance).

As with the initial decision to grant ASCA Accreditation to a testing laboratory, the decision to
withdraw ASCA Accreditation is discretionary. FDA may decide to withdraw ASCA
Accreditation for other reasons not listed above.

2. Implications for ASCA activities
Withdrawal of a testing laboratory’s ASCA Accreditation removes the testing laboratory from
the ASCA Pilot. Any activities performed after withdrawal of ASCA Accreditation should not be
identified as being performed as part of the ASCA Pilot.
Withdrawal of a testing laboratory’s ASCA Accreditation may affect the accreditation body that
accredited it for the ASCA Pilot, depending on the reasons for withdrawal (Refer to Section
X.F.1. of this guidance). Premarket review considerations for testing conducted after withdrawal
of a testing laboratory’s ASCA Accreditation are provided in Section XIII.B. of this guidance.
If FDA withdraws a testing laboratory’s ASCA Accreditation, an accreditation body’s own
decision regarding that laboratory is not necessarily affected. An accreditation body may

See section 514(d)(2)(B) of the FD&C Act.

Contains Nonbinding Recommendations
continue to accredit the testing laboratory; however, FDA would no longer recognize that
accreditation for purposes of the ASCA Pilot.

3. Procedures
When a testing laboratory’s ASCA Accreditation is withdrawn (and the organization is, therefore,
removed from the ASCA Pilot), FDA intends to send a withdrawal letter via email to the contact
on record for the testing laboratory. The letter will include the reason for the withdrawal and, if
appropriate, how the issues identified may be addressed in a future, new application for ASCA
Accreditation. A testing laboratory may voluntarily request withdrawal of its ASCA
Accreditation by submitting an email to ASCA@fda.hhs.gov. To facilitate processing, FDA
recommends that a testing laboratory’s request to withdraw from the ASCA Pilot include the
ASCA Testing Laboratory Identification Number. FDA intends to confirm the withdrawal with
the contact on record within 14 calendar days of receipt of a request for voluntary withdrawal.
Upon withdrawal of a testing laboratory’s ASCA Accreditation, FDA will update the ASCA
website as appropriate and notify the accreditation body that accredited that testing laboratory for
the ASCA Pilot. Considerations for the accreditation body are discussed in Section X.F.1. of this
guidance.
If a testing laboratory wishes to participate in the ASCA Pilot after withdrawal of its ASCA
Accreditation, the organization should submit a new application for ASCA Accreditation
following the same procedures for an initial application as outlined in this guidance. FDA
recommends that the new application for ASCA Accreditation include the ASCA Testing
Laboratory Identification Number and indicate whether the withdrawal was voluntary. If
withdrawal was not voluntary, FDA recommends the application include reference to FDA’s
letter and explain how all issues identified in the withdrawal letter were addressed.

XII. Processes and Policies for Device Manufacturers
A.

Selection of an ASCAaccredited Testing Laboratory

Device manufacturers may voluntarily choose to use an ASCA-accredited testing laboratory to
conduct testing included in a premarket submission. The ASCA website provides an up-to-date
listing of ASCA-accredited testing laboratories (including their scopes of and expiration dates for
ASCA Accreditation). In selecting an ASCA-accredited testing laboratory, FDA recommends
that a device manufacturer consider the FDA-recognized consensus standards and test methods
within a testing laboratory’s scope of ASCA Accreditation in comparison to the testing the device
manufacturer plans. A device manufacturer may wish to stipulate in their contract with an
ASCA-accredited testing laboratory that the testing laboratory notify the device manufacturer if
the testing laboratory’s ASCA Accreditation is suspended or withdrawn.

Development of a Test Plan

The ASCA Pilot does not alter the device manufacturer’s responsibility to ensure FDArecognized consensus standards and test methods are selected and used appropriately as

Contains Nonbinding Recommendations
described in FDA’s guidance Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices. Given an ASCA-accredited testing laboratory’s expertise, a
manufacturer may choose to work with them in developing a test plan for their device. FDA
recommends that development of a test plan for conduct by an ASCA-accredited testing
laboratory consider the following:
·

Other FDA guidance and FDA-recognized consensus standards.
FDA recommends that a test plan consider all relevant FDA guidance (e.g., device
type guidance, scientific area guidance, submission type guidance) and FDArecognized consensus standards. For example, FDA recommends that a test plan for
basic safety and essential performance consider the collateral and particular standards
to determine the most efficient and appropriate test plan. As another example, FDA’s
guidance Bone Anchors- Premarket Notification (510(k)) Submissions68 provides
specific recommendations for a bone anchor 510(k) submission, including
performance test recommendations such as biocompatibility testing.

Impact of deviations from FDA-recognized consensus standards.
Modifications to the methods and/or acceptance criteria included within an FDArecognized consensus standard may be appropriate for a specific device based on its
intended use. When a standard permits such modifications, the modifications do not
affect compliance with the standard and, therefore, a DOC is appropriate. However,
if the standard does not permit the modifications used during testing, the
modifications would be considered deviations and the testing would not be
considered to have been conducted in compliance with the standard. A DOC would
not be appropriate for testing that includes deviations. Testing that includes deviations
(and for which a DOC would not be appropriate)69 does not meet the criteria for
inclusion in the ASCA Pilot and the premarket review considerations described in
Section XIII. of this guidance do not apply. This is because, under the ASCA Pilot,
device manufacturers may include in their premarket submissions DOCs based on
testing from ASCA-accredited testing laboratories.70 Deviations (i.e., modifications
not specifically allowed by the FDA-recognized consensus standard) necessarily
indicate that a device does not conform to the standard; therefore, a DOC would not
be appropriate. Note that the testing may still be appropriate for general use of
consensus standards as described in FDA’s guidance, Appropriate Use of Voluntary
Consensus Standards in Premarket Submissions for Medical Devices.

Testing outside of a testing laboratory’s scope of ASCA Accreditation.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bone-anchorspremarket-notification-510k-submissions
69
See section IV.B. of FDA’s guidance Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices
70
See section 514(d)(1)(B) of the FD&C Act.

Contains Nonbinding Recommendations
A test plan may include some methods that are and some methods that are not
included in a testing laboratory’s scope of ASCA Accreditation. The processes and
policies within this guidance and other relevant standards-specific ASCA Pilot
guidances, including the ASCA program specifications applicable to the specific
FDA-recognized consensus standards and test methods, apply to all testing conducted
within a testing laboratory’s scope of ASCA Accreditation. The premarket review
considerations discussed in Section XIII. of this guidance apply only to testing
conducted by an ASCA-accredited testing laboratory within their scope of ASCA
Accreditation. Section XII.C. of this guidance describes how to clarify in a premarket
submission which testing was conducted within the ASCA Pilot and which was not.
For testing not within a testing laboratory’s scope of ASCA Accreditation, please see
FDA’s guidance, Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices.
·

Q-Submission.
A device manufacturer may follow the policies and procedures in FDA’s guidance
Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program71 to receive feedback from FDA regarding a proposed test plan.

Contents of a Premarket Submission

Testing performed by an ASCA-accredited testing laboratory can be used to support a premarket
submission for any device if the testing was conducted using an FDA-recognized consensus
standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the
ASCA program specifications for that standard and test method. The ASCA Pilot does not alter
the device manufacturer’s responsibility to address relevant information in the premarket
submission. This includes the responsibility to document how testing supports premarket
authorization, even when such testing is performed by an ASCA-accredited testing laboratory.
As mentioned in Section IV. of this guidance, this guidance document does not address specific
content for a particular premarket submission. Rather this guidance document describes how a
device manufacturer may incorporate testing results from an ASCA-accredited testing laboratory
into its premarket submissions. Device manufacturers should also review FDA’s guidance
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices, which further describes recommended premarket submission content when an FDArecognized consensus standard is used.

1. Cover Letter
FDA recommends that manufacturers include the following information in the cover letter for a
premarket submission containing testing results from an ASCA-accredited testing laboratory.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-andmeetings-medical-device-submissions-q-submission-program

Contains Nonbinding Recommendations
·
·
·
·

Clear identification of the term “ASCA”
Name(s) and location(s) of the testing laboratory(ies) where testing was conducted
ASCA Testing Laboratory Identification Number(s)
FDA-recognized consensus standard(s) (and specific test methods) used during testing.
Note: The premarket review considerations in Section XIII. of this guidance apply only to
FDA-recognized consensus standards (and specific test methods) within the laboratory’s
scope of ASCA Accreditation at the time of testing.

2. Declaration of Conformity (DOC)
Section IV.A. of FDA’s guidance, Appropriate Use of Voluntary Consensus Standards in
Premarket Submissions for Medical Devices recommends contents for a DOC to an FDArecognized consensus standard. For testing from an ASCA-accredited testing laboratory,
additional items are recommended for inclusion in a DOC depending upon the FDA-recognized
consensus standards and test methods used. For example, FDA recommends that the DOC
indicate whether the FDA-recognized consensus standards and test methods used were included
in the testing laboratory’s scope of ASCA Accreditation at the time of testing. Example DOCs are
provided in the standards-specific ASCA Pilot guidance documents. These examples illustrate
how one DOC might incorporate results from testing using FDA-recognized consensus standards
and test methods under the ASCA Pilot and outside of the ASCA Pilot.

3. Supplemental Documentation to Support a DOC
FDA’s guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
for Medical Devices describes when supplemental documentation (e.g., summary test report,
complete test report) is needed to support a DOC to an FDA-recognized consensus standard.
Recommended contents for supplemental documentation for testing conducted by an ASCAaccredited testing laboratory are provided in the standards-specific ASCA Pilot guidance
documents. Note that the ASCA-accredited testing laboratory provides to the device
manufacturer all information listed in the relevant ASCA program specifications (including the
ASCA summary test report). The device manufacturer then includes appropriate supplemental
documentation (e.g., ASCA summary test report) with its own DOC in a premarket submission
to FDA.

XIII.

Processes and Policies for FDA Review Staff

Use of a conformity assessment scheme to grant ASCA Recognition to accreditation bodies, grant
ASCA Accreditation to testing laboratories, and communicate with and audit both accreditation
bodies and testing laboratories provides FDA increased confidence in the methods used and
results reported by ASCA-accredited testing laboratories when testing is performed within the
testing laboratory’s scope of ASCA Accreditation.

General Premarket Review Policy

As part of their participation in the ASCA Pilot, ASCA-accredited testing laboratories agree to
use methodologies consistent with the FDA-recognized consensus standards and test methods in
their scope of ASCA Accreditation and the relevant ASCA program specifications. For this
36

Contains Nonbinding Recommendations
reason, FDA generally intends to rely on the results from ASCA-accredited testing laboratories
for the purpose of premarket review without the need for additional information related to
conformance with a standard. However, FDA retains the discretion not to accept determinations
(i.e., test results) from an ASCA-accredited testing laboratory if FDA “finds that a particular
such determination shall not be so accepted.”72 The following are examples of circumstances
where FDA is likely to question the validity of test methods within a testing laboratory’s scope
of ASCA Accreditation:
·
·
·
·

·
·
·

As part of periodic audits (Refer to Section X.E. and XI.E. of this guidance);73 or
If FDA becomes aware of information that would result in suspension or withdrawal of a
testing laboratory’s ASCA Accreditation; or
If FDA becomes aware of information that would result in withdrawal of the associated
accreditation body’s ASCA Recognition; or
If FDA becomes aware of information materially bearing on the study conduct or quality
(e.g., if the testing laboratories under the purview of 21 CFR 58 receive from FDA
Bioresearch Monitoring Program a warning letter including issues that could potentially
impact the testing in their scope of ASCA Accreditation); or
If FDA becomes aware of information materially relevant to safety or effectiveness for
the device 74 (e.g., if specific use issues of public health concern are identified for a
device type during total product lifecycle reviews); or
If the ASCA summary test report indicates an issue with the testing or device75 (e.g.,
controls do not work as expected or test results signal a possible issue with safety or
performance); or
If basic administrative information is missing (e.g., product identification information or
dates of testing);
If supplemental documentation to support the DOC (e.g., ASCA summary test report) is
incomplete; or
As noted in the standards-specific ASCA Pilot guidance documents for certain instances.

In these cases, additional questions may be asked to determine whether the test results can be
used to support a decision on a premarket submission.

Impact of Suspension of ASCA Accreditation

As discussed in Section XI.F.1. of this guidance, FDA will suspend a testing laboratory’s ASCA
Accreditation when specific issues are identified that raise potential concerns with the results
from that specific laboratory. When evaluating testing results conducted during a period of
suspension, FDA intends to carefully consider the issues resulting in the suspension as well as
which FDA-recognized consensus standards and test methods were subject to the temporary
labeling constraints of the suspension. Depending on the issues resulting in suspension and
which standards or test methods were suspended, FDA may be unable to rely solely on the

See section 514(d)(1)(B) of the FD&C Act.
See section 514(d)(2)(A) of the FD&C Act .
74
See section 514(d)(2)(B) of the FD&C Act.
75
See section 514 (d)(1)(B) of the FD&C Act.
73

Contains Nonbinding Recommendations
testing results provided in the premarket submission. In these cases, FDA may need to review
additional information and/or ask questions to determine whether the test results can be used to
support a decision on a premarket submission.

Impact of Withdrawal of ASCA Accreditation

As discussed in Section XI.G.1. of this guidance, FDA will withdraw a testing laboratory’s
ASCA Accreditation when FDA no longer believes the premarket review benefits of the ASCA
Pilot are appropriate for testing conducted at the testing laboratory. A manufacturer may still
include in their premarket submission a DOC for testing conducted at the testing laboratory. In
these cases, FDA would apply the policies described in FDA’s guidance Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical Devices, regarding
review of the associated DOCs (and the need for supplemental documentation to support a
DOC).
Withdrawal of a testing laboratory’s ASCA Accreditation may indicate the need for FDA to take
postmarket action. FDA intends to carefully consider the reason for withdrawal when
determining what postmarket action, if any, is appropriate for closed premarket submissions that
included testing results from an ASCA-accredited testing laboratory from which ASCA
Accreditation has been withdrawn. For example, if the nature and severity of the reasons for
withdrawal might have impacted the testing results supporting the submission decision, FDA
may engage with the device manufacturer to better understand device performance and
evaluation, review Medical Device Reports (MDRs) for signs of post market performance issues,
or conduct other compliance actions. In all cases, FDA intends to carefully weigh the benefits
and risks to patients when considering what, if any, action should be taken.
Note that withdrawal of an accreditation body’s ASCA Recognition affects FDA review
indirectly in that the withdrawal may result in suspension or withdrawal of the associated testing
laboratory’s ASCA Accreditation (Refer to Section XI.F.1. and XI.G.1. of this guidance).

XIV.

Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
The time required to complete this information collection is estimated 76 to average 95 hours per
response for accreditation bodies and 47 hours for testing laboratories. Send comments regarding
this burden estimate or suggestions for reducing this burden to:
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,

Rounded to the nearest whole number.

Contains Nonbinding Recommendations
PRAStaff@fda.hhs.gov

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number
for this information collection is 0910-0889 (expires 06-30-2023).

Contains Nonbinding Recommendations

Appendix A: Application for ASCA Recognition
FDA recommends that an application from an accreditation body seeking ASCA Recognition
include the following components:

Administrative Information

A.
·
·
·

Organization name and address
Designated point of contact: first and last name, title, phone number, and email
address
Alternate designated point of contact: first and last name, title, phone number, and
email address

Scope of ASCA Recognition

Indication of the requested scope of ASCA Recognition from the list of FDA-recognized
consensus standards and test methods in the ASCA Pilot (more than one standard and test
method may be identified).

Information in Support of Competence

Information demonstrating ability to participate in the ASCA Pilot.
·
·
·

Proof of signatory status as International Laboratory Accreditation Cooperation
(ILAC) MRA with scope that includes testing: ISO/IEC 17025.
Confirmation that accreditation body is based in the United States.
A current list and description of any accreditation services offered for which the
scope includes any of the FDA-recognized consensus standards or test methods in
the ASCA Pilot.
An example scope of accreditation that is typically used by the accreditation
body, and to what extent it will be modified to address accreditation for the
ASCA Pilot.
A detailed description of the process to accredit testing laboratory applicants to
ISO/IEC 17025 and ASCA program specifications to include awareness, training,
and accreditation activities.
A detailed description of the approach to assess procedures and corrective actions
as related to the most recent inspection findings noted by FDA Bioresearch
Monitoring Program per 21 CFR Part 58 – Good Laboratory Practice (GLP) for
Nonclinical Laboratory Studies for testing laboratory applicants with biological

Contains Nonbinding Recommendations

evaluation of medical device standards and test methods in their scope of
accreditation.77
A detailed description of the accreditation body’s approach used to determine
technical competency of testing laboratories consistent with ASCA program
specifications. This includes a detailed description of the qualifications for
technical assessors for the requested scope of ASCA Recognition. A description
could include resumes, CVs, summary of experience, relevant technical training,
etc., from personnel already identified.
A detailed description of the policy and processes concerning corrective actions
and the approach for responding to, investigating, and resolving complaints
against testing laboratories.

Signed Agreement

Confirmation that the accreditation body has read, understood, and agrees to adhere to the
following for its ASCA Pilot-related activities:
·

·
·

·
·
·
·

Maintain scope of signatory status to International Laboratory Accreditation
Cooperation (ILAC) Mutual Recognition Arrangement (MRA) that includes
ISO/IEC 17025.
Verify conformance with ISO/IEC 17025 and ASCA program specifications
when accrediting testing laboratories for the ASCA Pilot.
Follow the expectations (outlined in the standards-specific ASCA Pilot guidance
documents) regarding which FDA-recognized consensus standards and test
methods to assess when accrediting and assessing a testing laboratory for the
ASCA Pilot.
Provide all ASCA Pilot accreditation documentation to FDA upon request.
Allow FDA to participate as an observer during the accreditation body’s ILAC
MRA peer evaluation(s).
Allow FDA to participate as an observer during the accreditation body’s
assessment of a testing laboratory.
Commit that all relevant FDA training will be completed by appropriate
individuals prior to providing any accreditation to testing laboratories under the
ASCA Pilot.
Establish and maintain appropriate communication with FDA. An accreditation
body should not hesitate to contact FDA regarding the ASCA Pilot. FDA expects
that appropriate communication includes the following at a minimum:
§ Notification to FDA within five calendar days via email of any changes
that may impact the accreditation body’s participation (e.g., change to
scope of signatory status to ILAC MRA).

As discussed at the public workshop titled “Accreditation Scheme for Conformity Assessment of Medical Devices
to Food and Drug Administration-Recognized Standards,” biocompatibility testing conducted under the ASCA Pilot
will be conducted in accordance with 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies
regulations.

Contains Nonbinding Recommendations
§

·
·

Notification to FDA within five calendar days via email of any changes
that may impact the participation of any of the testing laboratories that the
accreditation body has accredited.
§ Attendance at regularly scheduled teleconferences with FDA as requested.
§ Provision of status updates annually or upon request to FDA including the
following information regarding the accreditation body’s ASCA Pilot
activities:
· Complaint handling;
· Total number and list of testing laboratories the accreditation body
has accredited, including dates of accreditation;
· Number and nature of non-conformities the accreditation body has
observed during accreditation or auditing of testing laboratories;
· Number of suspensions issued by the accreditation body for testing
laboratories; and
· Results of the accreditation body’s management reviews.
Establish and maintain policies and procedures that incorporate feedback from
FDA.
Acknowledge that FDA maintains complete discretion regarding granting ASCA
Recognition to an accreditation body. FDA may withdraw ASCA Recognition at
any time.
Confirm, to the best of your knowledge, all information submitted to FDA is
truthful and accurate and that no material fact has been omitted.

Contains Nonbinding Recommendations

Appendix B: Application for ASCA Accreditation
FDA recommends that an application from a testing laboratory seeking ASCA Accreditation
include the following components. If a testing laboratory application will be for multiple testing
sites, documentation should be clear with respect to the site to which it applies.

Administrative Information

A.
·
·
·

Scope of ASCA Accreditation

Indication of the requested scope of ASCA Accreditation from the list of FDA-recognized
consensus standards and test methods in the ASCA Pilot (more than one standard and test
method may be chosen).

Information in Support of Competence

Information demonstrating ability to participate in the ASCA Pilot.
·

Proof of testing laboratory accreditation that shows:
o The accreditation is from an ASCA-recognized accreditation body.
o The scope of ASCA Recognition for the accreditation body includes the scope for
which they accredited the testing laboratory.
o The scope of accreditation provided by the ASCA-recognized accreditation body
to the testing laboratory matches the testing laboratory’s requested scope of ASCA
Accreditation.

A copy of the Index of SOPs and any relevant ASCA test-related documents (e.g.,
SOPs, work instructions, master protocols, test-specific protocols, data collection
worksheets, training information) applicable to any biocompatibility testing of
medical device standards and test methods if included in the requested scope of ASCA
Accreditation.

Signed Agreement

Confirmation that the testing laboratory has read, understood, and agrees to adhere to the
following for its ASCA Pilot-related activities:
·

Conduct testing in accordance with ISO/IEC 17025, and the relevant ASCA
program specifications

Contains Nonbinding Recommendations
·
·
·
·
·

·
·
·

Be aware of and consider recommendations made in any relevant FDA guidance
documents.
Abide by the ASCA program specifications to achieve and maintain status as an
ASCA-accredited testing laboratory.
Provide all ASCA Pilot documentation (e.g., complaint logs, issue tracking, test
procedures) to FDA upon request.
Allow FDA to conduct audits upon request; audits may include observations of
testing activities and documentation review.
Establish and maintain appropriate communication with FDA. A testing
laboratory should not hesitate to contact FDA regarding the ASCA Pilot. FDA
expects that appropriate communication includes the following at a minimum:
§ Notification to FDA within five calendar days via email of any changes
that may impact the testing laboratory’s participation.
§ Attendance at regularly scheduled teleconferences with FDA as requested.
Regular interactions between testing laboratories and FDA are intended to
provide the opportunity for discussions about ASCA implementation
issues, e.g., training needs, possible improvements and other programrelated topics. FDA plans to hold these teleconferences with testing labs as
a group, not with individual laboratories.
§ Provision of annual reports of complaint handling to FDA.
Commit that all relevant FDA training will be completed by appropriate
individuals prior to conducting testing under the ASCA Pilot.
Ensure that proprietary information is protected per client agreements.
Acknowledge that FDA maintains complete discretion regarding granting ASCA
Accreditation in the ASCA Pilot. FDA may suspend or withdraw ASCA
Accreditation at any time.
Confirm, to the best of your knowledge, all information submitted to FDA is
truthful and accurate and that no material fact has been omitted.

File Type	application/pdf
File Title	The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing L
Author	CDRH CBER
File Modified	2020-09-24
File Created	2020-09-24