FDA 3632 Guide for Preparing Product Reports for Lasers and Produ

Form Approved: OMB No. 0910-0025
Expiration Date: January 31, 2017

FORM FDA 3632 (2/14)
Guide for Preparing Product Reports for Lasers and
Products Containing Lasers

Public reporting burden for this collection of information is estimated to average 24 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paper Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
*Please do NOT send your completed document to this PRA Staff email address.*
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.

This guidance was written prior to the February 27, 1997 implementation of FDA’s
Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person
and does not operate to bind FDA or the public. An alternative approach may be used if
such approach satisfies the requirements of the applicable statute, regulations, or both.
This guidance will be updated in the next revision to include the standard elements of GGP’s.

More industry guidance and assistance can be found at the FDA homepage, see:
http://www.fda.gov/Radiation-EmittingProducts/ .

Send your completed report to:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
Questions about reporting and suggestions for changes to this guide may be sent to the above
address or may be discussed by calling 1-800-638-2041.

FORM FDA 3632 (2/14)

GUIDE FOR PREPARING PRODUCT REPORTS
FOR LASERS AND PRODUCTS CONTAINING LASERS

September 1995

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3632 (2/14)

This page is deliberately blank.

FORM FDA 3632 (2/14)

Foreword
The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will
assist manufacturers¹ of electronic products which emit radiation in providing adequate reporting of radiation safety testing
and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and
1003 specify Reporting and Notification requirements²,³.
Reports submitted on radiation safety of electronic products must follow the appropriate guide (21 CFR 1002.7). If the
report does not follow an applicable guide it must contain a sufficient justification for any deviations. The submitter of
the report will receive an acknowledgment letter with the accession number we assign to the report. Please reference this
accession number in the future when providing additional information about this model family in either a supplement or the
annual report. If a report is incomplete or inadequate CDRH may reject it and return it for completion. CDRH will not
enter a rejected report into our database. Also, a rejected report will not receive an accession number.
WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is the manufacturer’s
responsibility to certify that their products comply with all applicable standards (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. Prior to the shipment of products in interstate commerce
21 CFR 1002 requires the manufacturer to submit the report and to comply with all applicable importation requirements
(21 CFR 1005). If there are deficiencies, we may disapprove the firm’s quality control and testing program, determine
that the product contains a radiation defect, or determine that the product fails to comply with a standard. We will notify
the manufacturer if we make such a determination. CDRH may require the manufacturer to cease introduction into U.S.
commerce until deficiencies are corrected, and to initiate a corrective action program (21 CFR 1003 - 1004) for products
already introduced into commerce.
Please mail your reports to the address below (FDA can not process electronic submissions at this time). Provide the
original report with appropriate signature(s) (no facsimiles, please). Provide extra copies only if this guide specifically
requires them. Submit the report written in the English language. Translate any text that appears in a language other than
English into English in a complete and accurate manner. Keep a copy of the completed reports in your records.
We are making our reporting guides and other regulatory information available on the Internet under
http://www.fda.gov/Radiation-EmittingProducts/. No copyright exists for these guides. Reproduce these guides as needed.
If you would like to comment on the reporting guides, web site, or future electronic submissions, you may direct the comments
to the address below. If you need additional regulations for electronic products or medical devices, you should contact the
Division of Small Manufacturers, International and Consumer Assistance by telephone at 1-800-638-2041 or by facsimile at
301-847-8149.
Sincerely yours,

Lillian J. Gill
Director
Office of Compliance
E-MAIL ADDRESS: dsmica@fda.hhs.gov
MAILING ADDRESS (see 21 CFR 1002.7 for further information):
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DOCUMENT MAIL CENTER – WO66-G609
ATTN: ELECTRONIC PRODUCT REPORTS
10903 NEW HAMPSHIRE AVENUE
SILVER SPRING, MD 20993-0002
¹

Manufacturer (see 21) CFR § 1000.3 (n)) means any person engaged in the business of manufacturing, assembling, or importing electronic products.

²

Accidental Radiation Occurrences: 21 CFR 1002.20 requires manufacturers to immediately report accidental radiation occurrences (see 21 CFR
1000.3(a) for the definition).

³

Notification: Title 21 CFR Part 1003 requires manufacturers to provide Notification of Defects or Failure to Comply. Send these notifications to the
above address.

FORM FDA 3632 (2/14)

PREFACE
Manufacturers of products subject to performance standards under the Federal Food, Drug,
and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control are required
to furnish various reports to the Center for Devices and Radiological Health (CDRH). This
guide is for use by manufacturers of lasers and products containing lasers in preparing Product
Reports as required by paragraph 1002.10 and 1002.11 of Title 21 CFR (Code of Federal
Regulations).
This reporting guide incorporates all current changes and should be used in conjunction with the
companion publication, "Compliance Guide for Laser Products." You should read and
understand that guide and determine how your product complies with the regulations before
completing this report. To further assist you, relevant Sections of Title 21 CFR are cited in
parentheses throughout this guide.
If you have specific questions, write to the Center for Devices and Radiological Health,
Document Mail Center – WO66-G609, Attn: Electronic Product Reports, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, or call 1-800-638-2041, or e-mail us at
dsmica@fda.hhs.gov.

I. Paul Leggett, Chief
Nonmedical Radiological Devices
Branch Division of Enforcement III
Office of Compliance

ii
FORM FDA 3632 (2/14)

CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .

i

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ii

GENERAL INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iv

DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

vi

PART 1:

MANUFACTURER AND REPORT IDENTIFICATION . . . . . . . . . . . . . . . . . . . . . . .

1

PART 2:

PRODUCT AND MODEL IDENTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

PART 3:

COMPLIANCE WITH THE LABELING REQUIREMENTS . . . . . . . . . . . . . . . . . . . .

4

PART 4:

COMPLIANCE WITH THE INFORMATIONAL REQUIREMENTS . . . . . . . . . . . . . .

6

PART 5:

DESCRIPTION OF THE PRODUCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

PART 6:

LEVELS OF ACCESSIBLE LASER RADIATION AND
CLASSIFICATION OF THE LASER PRODUCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

PART 7:

COMPLIANCE WITH THE PERFORMANCE REQUIREMENTS . . . . . . . . . . . . . . .

11

PART 8:

QUALITY CONTROL TESTS AND TESTING PROCEDURES . . . . . . . . . . . . . . . . .

21

PART 9:

LIFE AND ENDURANCE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22

PART 10: INSTRUMENTATION AND CALIBRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24

iii
FORM FDA 3632 (2/14)

GENERAL INSTRUCTIONS

Product Reports, Supplemental Reports, and Abbreviated Reports must be submitted to the Center for
Devices and Radiological Health (CDRH) at the address on the following page prior to introduction
of the reported products into commerce. (This includes products imported into the U.S.)
This guide should be followed for all lasers and products containing, incorporating, or intended to
incorporate, a laser or laser system [see the definition of "laser product" in section 21 CFR
1040.10(b)(21)]. A separate guide for reporting additional information concerning laser light shows
is being published concurrently with this guide and must be used in conjunction with this guide when
appropriate (Reporting Guide for Laser Light Shows and Displays).
A complete Product Report is required for each laser product model or model family. Product
Reports were formerly called Initial or Model Change Reports. Since these reports contain
essentially the same information, the single term, Product Report, is now used. CDRH suggests that a
complete report on one model of a family be submitted, with a separate Supplemental Report for
each of the other models in the family. The Supplemental Report should respond in detail to the
parts of the guide where there are differences to report, referencing the number of the affected item.
Items that are unchanged need only be referenced to the original report.
A new or modified model belonging to a previously reported model family must be reported in a
Supplemental Report on that model family prior to its introduction into commerce.
If an individual item or requirement of the standard is not appropriate for the laser product, so
indicate. In general, any aspect of the product that pertains to radiation safety should be reported,
including aspects not covered by the guide, such as special use conditions; other controls, indicators
or warnings; and aspects for which there are no applicable provisions
in sections 1040.10 and 1040.11.
Much of the information requested in this guide can be given in the space provided. Where
attachments are required, so indicate in the space provided in the body of the guide. Attachments
should be clearly numbered the same as the specific part of the guide to which they are addressed.
For example, an attachment responding to Part 3.2 should be labeled "Attachment 3.2."
The report for each laser product model family should be complete and separable from the reports for
other model families. However, certain information to be reported may be the same for two or more
model families, such as quality control and testing programs, instrumentation, and calibration
procedures. Such information may be fully reported in one model family report and referenced in
another. If this is done, the reference must be clear and unambiguous, including the CDRH
accession number, date, and item number.
The manufacturer must be sure that referenced information is accurate, current, and applicable to the
reported models. Information that is applicable to more than one model family, but cannot be
referenced in accordance with the above guidance, should be duplicated and included in each report.
When new models of a laser product are introduced, if the models satisfy the criteria for an
established reporting exemption or if the new models do not involve changes in radiation emission or
performance requirements, then the manufacturer need not report the models prior to introduction
into commerce. Rather, the manufacturer is only required to identify them in the annual report, or in
quarterly updates to the annual report. Quarterly updates to annual reports should be clearly marked
as such and be submitted prior to December 1, March 1, and/or June 1 when required. [See 21 CFR
1002.13(c).]
iv
FORM FDA 3632 (2/14)

All symbols, units, and unusual terms in the report must be adequately defined and
consistently used. Please use the terms as defined in Section 1040.10(b) and in the IEEE
Standard Dictionary of Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI
C42.1001972).
All reports and correspondence must be addressed to:
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
Attn: Electronic Product Reports
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
When a report is received at CDRH, a unique accession number will be assigned for future
reference. The submitter will be informed of the accession number in a letter of
acknowledgment, which should not be construed as a technical review of the report.
Submitters should clearly identify Supplemental Reports with the accession number of the
relevant Product Report.
The Product Reporting Guides and Annual Reporting Guides are available from the
Division of Small Manufacturer's Assistance (DSMA) in Rockville, Maryland at 1-800638-2041. DSMA should be contacted for requests of any current documents, including
information on medical device approval procedures, registration & listing of medical
devices, and the reporting guides mentioned here. If you have specific questions regarding
regulations or filling out these reports, call the Radiological Health staff at 1-800-638-2041,
or e-mail us at dsmica@fda.hhs.gov.

v
FORM FDA 3632 (2/14)

DEFINITIONS
NOTE: These definitions have been revised.
Product Report (21 CFR 1002.10) - A Product Report is a report submitted by a
manufacturer of a regulated product, e.g., laser products, sunlamps, TV. The Product Report
describes the product, details how the product complies with the standard, and explains the
quality control program to assure compliance. A Product Report can be used for families of
products as well as for individual products.
Supplemental Report (21 CFR 1002.11) - A Supplemental Report provides information
supplementary to a previously submitted Product Report. It is used to report a new
model in a previously reported model family, a modification of a previously reported model,
or other changes to a previous report (e.g., changes in testing programs, additions or
changes in user or service manuals, responses to CDRH report review letters).
Supplemental Reports are also required for changes that:
a. affect actual or potential emission,
b. decrease the degree of compliance with the performance standard, or
c. result in a decreased probability of detecting product noncompliance or
increased radiation emission.
Supplemental Reports should clearly reference the CDRH accession number of the Product
Report and the appropriate sections of this guide.
Annual Report (21 CFR 1002.13) - An Annual Report summarizing the required records
must be submitted by September 1 for the 12 months ending on June 30 of the same year. In
addition, the Annual Report is the appropriate vehicle for identifying new models for which
Supplemental Reports are not required. If the new models do not involve changes in
radiation emission or performance requirements, then the manufacturer need only identify
them in their annual report, or in quarterly updates to the annual report. Copies of the
annual report form to be followed are available from DSMA by calling 1-800-638-2041.
Model Family - A model family is a group of two or more laser product models with
basically similar design, performance features and intended function, manufactured under
the same or very similar quality control and testing procedures. Models within the same
family may have different outputs and different laser media and, in some cases, may belong
to different classes.
Applicability of reporting and recordkeeping requirements for laser products:
Class I laser products and Class I laser products containing Class IIa, II, and IIIa
lasers will require: Product Report, Annual Report, test records, manufacturer's
distribution records, and dealer/distributor distribution records.
Note that for these products, no Supplemental Reports are required. Furthermore,
some Class I laser products have already been exempted from the requirement
for distribution records (see Notices to Industry dated August 9, 1988, Laser
Notice #41, December 18, 1989, #42, and January 6, 2006, #54).

vi
FORM FDA 3632 (2/14)

Class IIIb and IV laser products require all of the above plus Supplemental
Reports when the criteria requiring submission of Supplemental Reports are
met.

vii
FORM FDA 3632 (2/14)

This page is deliberately blank.

FORM FDA 3632 (2/14)

LASER PRODUCT REPORT
PART 1: MANUFACTURER AND REPORT IDENTIFICATION
1.1

Manufacturer:
Manufacturing Firm
Address

Corresponding official:
Signature
Name & title
Email address

Telephone number

Firm's Prime Contact or Responsible Person if different from above:
Name & title
Email address

Telephone number
1.2

Importing agent (For manufacturers exporting to the U.S., see 21 CFR
1005.25.):
Signature
Or attach copy of written agreement with agent)
Name & title
Address

Email address

Telephone number
1.3

Report type:

(

) Laser Product Report, or

(

) Supplement to CDRH Accession No.

submitted on (date)
1.4

Date of this report:

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 1

PART 2: PRODUCT AND MODEL IDENTIFICATION
2.1

List all names, brand names, model numbers and model family designations of the laser
product being reported. If the product is sold by other companies under different brand
names, also give the names and addresses of the companies, the brand names, and the model
numbers, and indicate how the brand names and model numbers correspond with your own
brand names and model numbers.

2.2

Is your laser product the result of the modification of a laser product certified by another
manufacturer? [see 1040.10(i)]
(

) Yes

(

) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

NOTE: Modification involves any changes to the product that affect its classification,
performance or labeling requirements (as required by the standard or an approved
variance).
2.3

Does your laser product incorporate an unmodified, certified laser product?
(

) Yes

(

) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 2

2.4

Does your product incorporate a noncertified laser product?
(

) Yes

(

) No

If yes, identify the manufacturer(s), brand(s), model(s), and describe the type of product.

2.5

Does your laser product incorporate a removable laser system or systems as defined in
1040.10(c)(2)?
(

) Yes

(

) No

If yes, identify the manufacturer(s), brand(s), and model number(s).

2.6

If the laser product, as introduced into commerce, is not supplied with a laser or laser system
or the product does not incorporate a laser or laser system, report by manufacturer and
model number which laser or laser system, if any, is recommended by you for use with the
product.

2.7

If you do not recommend a specific laser or laser system for use with the reported product,
state the specifications of the laser or laser system to be incorporated.

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 3

PART 3: COMPLIANCE WITH THE LABELING REQUIREMENTS
For each of the following labels required for the product being reported, provide a sample or a
facsimile of each label. Clearly indicate the locations on the product of all required labels in your
response to this Part or to Part 5. Reference to diagrams, photographs, blueprints, product literature,
etc., is acceptable. See Compliance Guide, page 7, for assistance.
3.1

Certification label - Required on all laser products (1010.2).

Is the label (or a copy) submitted with this report?
(

) Yes

(

) No

(

) Yes

(

) No

Location on product:
3.2

Identification label - Required on all laser products (1010.3).

Is the label (or a copy) submitted with this report?

Location on product:
3.3

Warning logotype - Required on Class II, III, and IV laser products. [1040.10(g)(1), (2), (3),
(4), (8), (9), (10)].

Is the label (or a copy) submitted with this report?
(

) Yes

(

) No

(

) Yes

(

) No

Location on product:
3.4

Warning label - Required on Class IIa laser products [1040.10(g)(1)(i)].

Is the label (or a copy) submitted with this report?

Location on product:

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 4

3.5

Aperture label(s) - Required on Class II, III and IV laser products [1040.10(g)(5), (8), (9),
(10) or 1040.11(a)(3)].

Are the label(s) (or copies) submitted with this report?

(

) Yes

(

) No

Location on product:
3.6

Label(s) for noninterlocked protective housings [1040.10(g)(6), (8), (9), (10)].

Are the label(s) (or copies) submitted with this report?

(

) Yes

(

) No

(

) Yes

(

) No

(

) Yes

(

) No

(

) Yes

(

) No

Location on product:
Are the label(s) visible both prior to and during opening or removal of housing?
3.7

Label(s) for defeatably interlocked protective housings [1040.10(g) (7),
(8), (9), (10)].

Are the label(s) (or copies) submitted with this report?
Location on product:
Are the label(s) visible both prior to and during interlock defeat?

3.8

Label(s) for optionally interlocked protective housings. (See Laser Notice #17 of
March 2, 1977, dealing with optional interlocks.)

Are the label(s) (or copies) submitted with this report?

(

) Yes

(

) No

(

) Yes

(

) No

Location on product:
Are the label(s) visible both prior to and during opening or removal
of the housing?

NOTE: If the labeling requirements are inappropriate to your product, you may apply
for approval of alternate labeling. See sections 1010.2, 1010.3, and 1040.10(g)(10).

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 5

PART 4: COMPLIANCE WITH THE INFORMATIONAL REQUIREMENTS
4.1

Submit copies of user and servicing information (operator and service manuals) for your
laser product. If the manuals are very extensive, submit those portions that confirm
compliance with Section 1040.10(h) [and 1040.11(a)(2), if a medical laser product] and that
permit understanding how your laser product functions. See Compliance Guide, page 8, for
assistance.

Are copies of user and service information attached to this report?

(

) Yes

(

) No

If "Yes," please identify attachment:
If "No," please explain why not

NOTE: These materials may also be used in the product description required by Part 5.

4.2

Submit copies of any catalogs, specification sheets, and descriptive brochures for Class IIa,
II, III, and IV laser products.

Are copies of catalogs, specification sheets, or brochures attached to this report?
If "Yes," please identify attachment:

(

) Yes

(

) No

If "No," please explain why not

NOTE: This material is needed to demonstrate compliance with Section 1040.10(h)(2), which
states that a reproduction of the warning logotype is required in all catalogs,
specification sheets, and descriptive brochures.

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 6

PART 5: DESCRIPTION OF THE PRODUCT
5.1

Describe the product and its function. You may refer to brochures and manuals submitted
with this report. Please include drawings or photographs adequate to document compliance
of the product with the performance and labeling requirements.

Is a product description attached to this report?

(

) Yes

(

) No

Please identify attachment:
5.2

Describe the external and internal laser radiation fields and paths. Beam path diagrams
indicating protective housing, beam attenuators, viewports, scanners, targets, etc.
would be helpful. Please identify external and internal laser power or energy levels where
applicable.

Are description and diagrams of the laser radiation fields and paths attached?
(

) Yes

(

) No

Please identify attachment:
5.3

List the procedures performed during operation and indicate those collateral and laser
radiation fields specified in Part 6 to which human access is possible when those procedures
are being performed. [See definition of human access - Section 1040.10(b)(15)].

Operational procedures and accessible radiation:

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 7

5.4

List the procedures performed during maintenance and indicate those collateral and laser
radiation fields specified in Part 6 to which human access is possible when those procedures
are being performed. See the definition of maintenance in section 1040.10(b)(24) and
Compliance Guide, page 5.

Maintenance procedures and accessible radiation:

5.5

List the procedures performed during service and indicate those collateral and laser radiation
fields specified in Part 6 to which human access is possible when those procedures are being
performed.

Service procedures and accessible radiation:

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 8

PART 6: LEVELS OF ACCESSIBLE LASER RADIATION AND
CLASSIFICATION OF THE LASER PRODUCT
6.1

Give the specifications of all laser radiation fields described in Part 5 to which human access
is possible during operation. See Section 1040.10(e) for measurement parameters. Indicate
whether the values are measured or based on calculations. Whether measured or calculated,
please provide a diagram of your measurement/calculation set-up, and pertinent dimensions
such as separation distances, source and detector aperture size, etc. in order to show how
your measurements or calculations are in accordance with 1040.10(e).

Please provide as much of the following as is appropriate to your product:
wavelength(s):

nm
W

maximum average radiant power:
degrees/radians

beam divergence:

mm

beam diameter at laser aperture:
if pulsed: pulse energy:

J

peak power:
pulse durations:

W
sec

repetition rate:
if applicable:
maximum irradiance or radiant exposure:
max. radiance or integrated radiance:

W or J cm-2
W or J cm-2 sr-1

Are measurement parameters, diagrams, calculations, and/or specifications submitted as an
attachment to this report?
(

) Yes - Please identify attachment:

(

) No

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 9

6.2

Indicate the Class of the laser product, based on your response to Part 6.1.

(

) Class I

(

) Class IIa

(

) Class II

(

) Class IIIa

(

) Class IIIb

(

) Class IV

6.3

Give the specifications of all possible laser radiation fields described in Part 5 to which
human access is possible during maintenance.

Are specifications attached?
6.4

) Yes

(

) No

Give the specifications of all possible laser radiation fields described in Part 5 to which
human access is possible during service.

Are specifications attached?

6.5

(

(

) Yes

(

) No

Describe all collateral radiation associated with the product. Report the source(s) and levels
and describe where and under what circumstances such radiation is accessible.

Is description attached?

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

(

) Yes

(

) No

Page 10

PART 7: COMPLIANCE WITH THE PERFORMANCE REQUIREMENTS
7.1

Protective housing - Required for all laser products [1040.10(f)(1)]
7.1.1

Describe the product's protective housing and how it serves to prevent unnecessary
human access to laser radiation.

Is additional information attached?
7.1.2

) Yes

(

) No

Describe how the protective housing prevents access to unnecessary collateral
radiation.

Is additional information attached?
7.2

(

(

) Yes

(

) No

Safety interlocks - Applicable for all laser products [1040.10(f)(2)(i)]
7.2.1

Provide a detailed mechanical diagram showing the location of each interlock
incorporated into the laser product for radiation safety.
Is a mechanical diagram attached?

(

) Yes

(

) No

Describe each interlock and explain how each such interlock prevents access to laser
and/or collateral radiation when each portion of the protective housing is opened.

Is additional information attached?

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

(

) Yes

(

) No

Page 11

7.2.2

Provide an electrical block diagram illustrating the logic of the interlock system.
Is an electrical diagram attached?

7.2.3

7.3

) Yes

(

) No

For each safety interlock, state whether actuation is intended during operation,
maintenance, service, or any combination thereof.

Is additional information attached?
7.2.4

(

(

) Yes

(

) No

For each safety interlock, state the highest level of laser radiation and collateral
radiation to which access is prevented.

Defeatable safety interlocks - Applicable to all laser products [1040.10(f)(2)(ii)
and (iii)]
7.3.1

Identify which safety interlocks are designed to allow defeat and describe how they
operate.

Is additional description attached?
7.3.2

) Yes

(

) No

For each safety interlock designed to allow defeat, state whether defeat is intended
during operation, maintenance, service, or any combination thereof.

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

(

Page 12

7.4

7.3.3

For each safety interlock designed to allow defeat, describe how replacement of a
removed or displaced portion of the protective housing is not possible while the
safety interlocks are defeated.

7.3.4

For each safety interlock designed to allow defeat, describe the means of providing a
visible or audible indication of defeat.

Safety interlock failure - Applicable to all required safety interlocks [1040.10(f)(2)(iii)] that
prevent access to Class IIIb or IV levels of laser radiation.
7.4.1

Describe how each safety interlock is "fail-safe," i.e., precludes removal or
displacement of the interlocked portion of the protective housing upon failure of the
safety interlock or is redundant.

Are electrical/mechanical diagrams or additional information attached?
(
7.4.2

(

) No

Describe the possible modes of failure of each safety interlock and the resultant
effect upon the radiation safety of the laser product.

Is additional information attached?

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

) Yes

(

) Yes

(

) No

Page 13

7.4.3

7.5

State the rating of each safety interlock, including the number of operational cycles
before failure.

Remote interlock connector - Applicable to Class IIIb or IV laser systems [1040.10(f)(3)]
7.5.1

Describe the electrical and mechanical construction and operation of the remote
interlock connector. Give its circuit and physical location.

Are electrical/mechanical diagrams or additional information
attached?
7.5.2

(

) Yes

(

) No

Record the open-circuit electrical potential difference between the terminals of the
remote interlock connector.
Volts

7.6

Key control - Required for Class IIIb or IV laser systems [1040.10(f)(4)]
7.6.1

Describe the electrical and mechanical construction of the key-actuated master
control.

Are electrical/mechanical diagrams or additional information
attached?
7.6.2

) Yes

(

) No

Describe the function of the key-actuated master control and how it renders the laser
inoperable when the key is removed.

Are electrical/mechanical diagrams or additional information
attached?

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

(

(

) Yes

(

) No

Page 14

7.6.3
7.7

Is the key removable in the "On" position?

(

) Yes

(

) No

Laser radiation emission indicator - Required for Class II, IIIa, IIIb, or IV laser systems
[1040.10(f)(5)]
7.7.1

Describe in detail the mechanical and electrical characteristics of all emission
indicators installed pursuant to Section 1040.10(f)(5)(i) or (ii) and give their
locations. Note that if the energy source and remote controller(s) are separable by
more than 2 meters, then each control must have an emission indicator.

Are electrical/mechanical diagrams or additional information attached?
(
7.7.2

(

) No

Record the length of time each emission indicator of Class IIIb and IV laser systems
is actuated prior to the emission of accessible laser radiation.
Emission indicator delay:

7.8

) Yes

sec

Protective eyewear - Applicable to Class II, IIIa, IIIb, or IV laser systems [1040.10(f)(5)(iv)]
State whether protective eyewear is supplied or recommended for use with the laser system.
If so, confirm that any visible emission indicator can be clearly seen through the protective
eyewear.
Is protective eyewear supplied?

(

) Yes

(

) No

Is it recommended?

(

) Yes

(

) No

Can visible emission indicators be seen through eyewear?

(

) Yes

(

) No

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FORM FDA 3632 (2/14)

Page 15

7.9

Beam attenuator - Required for Class II, IIIa, IIIb, or IV laser systems [1040.10(f)(6)]
7.9.1

For each beam attenuator, describe the mechanical and electrical characteristics and
how, when actuated, the attenuator prevents access by any part of the human body to
all laser and collateral radiation in excess of the accessible emission limits of Class I
and Table VI.

Are electrical/mechanical diagrams or additional information attached?
(
7.9.2

) Yes

(

) No

Describe the permanency of attachment of each beam attenuator.

NOTE: You may apply for approval of alternate means of providing this
protection if a beam attenuator is inappropriate to the product.
7.10

Location of controls - Applicable to Class II, IIIa, IIIb, or IV laser products [1040.10(f)(7)]
Explain how the location of each of the operation and adjustment controls of the laser
product is such that human exposure to laser or collateral radiation in excess of the
accessible emission limits of Class I and Table VI is prevented during operation or
adjustment of such controls.

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FORM FDA 3632 (2/14)

Page 16

7.11 Viewing optics - Applicable to all laser products [1040.10(f)(8)]
7.11.1 State whether all laser and collateral radiation accessible by virtue of viewing optics,
viewports, and display screens incorporated into the reported model of laser product
is less than the accessible emission limits of Class I and Table VI during operation
and maintenance. Include with your calculations pertinent attenuation factors,
window transmission characteristics, etc.

Are electrical/mechanical diagrams or additional information attached?
(

) Yes

(

) No

REMINDER: Report in Part 5 the location and identification of laser and collateral
radiation made accessible by viewing optics, viewports, and display screens. In Part 6,
report the highest levels.
7.11.2 Describe in detail, using diagrams or photographs and radiation transmission or
reflection spectra, each shutter or variable attenuator incorporated into viewing
optics, viewport, or display screen. Describe how exposure of the eye to laser or
collateral radiation in excess of the accessible emission limits of Class I and Table VI
is prevented whenever the shutter is opened or the attenuator is varied.

Are diagrams/photographs or additional information attached?
(

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

) Yes

(

) No

Page 17

7.11.3 Describe how exposure of the eye to laser or collateral radiation in excess of the
accessible emission limits of Class I and Table VI is prevented in the event of failure
of the shutter or variable attenuator, as required by Section 1040.10(f)(8)(ii).

Are diagrams or additional information attached?

7.12

(

) Yes

(

) No

Scanning safeguard - Required for certain laser products with scanned laser radiation
[1040.10(f)(9)].
Describe the mechanical, electrical, and functional characteristics of any required scan
failure safeguard. Include calculations to show that the safeguard's reaction time is adequate
for compliance with this section.

Are electrical/mechanical diagrams, calculations, or additional information attached?
(

) Yes

(

) No

NOTE: A safeguard is required when scan failure would cause the product to exceed
the emission limits of the class of the product, or in the case of Class IIIb or IV laser
products would cause the accessible emission limits of Class IIIa to be exceeded.
7.13

Manual reset - Applicable to Class IV laser systems manufactured after August 20, 1986.
Provide the circuit and physical description and location of the means provided to require
manual restart following interruption of emission caused by power failure of at least 5
seconds or deactivation through the remote interlock connector.

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7.14

Medical laser product - Applicable to Class III or IV medical laser products intended for
in-vivo surgical, therapeutic, or diagnostic irradiation of the human body.
NOTE: The requirement in section 1040.11(a) does not apply to visible aiming beams
less than the accessible emission limits of Class IIIa except for ophthalmic
indications.
If your product is a Class III or IV medical laser product, provide the following
information:
7.14.1 Describe the means incorporated into the product to measure the level of laser
radiation intended for irradiating the human body; include circuit diagrams and/or
optical system diagrams.

Are electrical/mechanical diagrams, calculations, or additional information
attached?
( ) Yes (

) No

7.14.2 Specify the uncertainty in the measurement system and describe the method by which
it was derived.

Are calculations or additional information attached?

(

) Yes

(

) No

7.14.3 Is the displayed power/energy level measured at the point of delivery or earlier
and then calculated? If the displayed level is calculated incorporating system
constants, losses, attenuation factors, etc., please provide calculations to demonstrate
accurate calibration of the delivered beam to within + or - 20%, as required by
1040.11(a)(1).

Are calculations or additional information attached?

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

(

) Yes

(

) No

Page 19

7.14.4 Are procedures and a schedule for recalibration of the measurement system included
in the user instructions?
( ) Yes ( ) No
If yes, please identify location in the user instructions:

7.15

Surveying, leveling, or alignment laser products - Is the product a surveying, leveling, or
alignment laser product?
( ) Yes ( ) No
If yes, then it is subject to the requirements of section 1040.11(b). If the product's class
exceeds Class IIIa then an approved variance from the performance requirements in this
section would be necessary prior to introduction into commerce. Procedures for applying for
a variance are given in section 1010.4, and described in the Compliance Guide, page 13.

7.16

Demonstration laser products - Is the product a demonstration laser product?
(

) Yes

(

) No

If yes, then it is subject to the requirements of section 1040.11(c). If the product's class
exceeds Class IIIa then an approved variance from the performance requirements in this
section would be necessary prior to introduction into commerce. Procedures for applying for
a variance are given in the Compliance Guide, pages 13 and 16-22.
An Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or
Device (form FDA 3147) must be submitted, following the instructions on the form. A
Laser Light Show report may also be required if you intend to produce shows or displays
with Class IIIb or Class IV demonstration laser products. The Reporting Guide for Laser
Light Shows and Displays should be filled out and submitted along with this report and the
variance application, following the instructions in each document.
7.16.1 Is a Variance application being submitted along with this report?
(

) Yes - date of submission:

(

) No

(

) No

7.16.2 Is a Laser Light Show report being submitted along with this report?
(

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

) Yes - date of submission:

Page 20

PART 8: QUALITY CONTROL TESTS AND TESTING PROCEDURES
8.1

8.2

Attach, and identify as attachments to Part 8, samples of documents that describe, specify, or
relate to procedures or tests used to ensure compliance of your reported product with the
standard, including compliance with all performance, labeling, and informational
requirements. These may include:
(

)

specification controls for critical components,

(

)

manufacturing and assembly control procedures,

(

)

inspection and test control procedures,

(

)

assembly and test traveler forms,

(

)

inspection and test reports and checklists, and/or

(

)

other(s)

(specify)

If formal quality control and testing procedures have not been implemented or are not
sufficient to assure that your product(s) will comply with the standard, explain how you
assure that your products comply and submit supporting documentation.

NOTE: Section 1010.2(c) requires that certification be based on a test, in accordance
with the standard, of each unit or on a program in accordance with good manufacturing
practices. Failure to maintain an adequate testing program may result in disapproval
of the program by CDRH.

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FORM FDA 3632 (2/14)

Page 21

PART 9: LIFE AND ENDURANCE TESTING
Describe those tests and controls used to ensure that the reported product will remain in compliance
with the Federal laser product performance standard during its useful life. Items to be addressed
include:
9.1

Dimensional stability and rigidity of mechanical parts and assemblies such as housings and
mounts

Is additional information/documentation attached?

9.2

(

) Yes

(

) No

(

) Yes

(

) No

Design and ratings of electrical and electronic components

Is additional information/documentation attached?

9.3

Environmental stability of components such as filter materials, coatings, and adhesives

Is additional information/documentation attached?
(

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

) Yes

(

) No

Page 22

9.4

Design and testing of features designed to meet Federal laser product performance
requirements

Is additional information/documentation attached?

9.5

(

) Yes

(

) No

(

) Yes

(

) No

Other factors that might affect your product's radiation safety

Is additional information/documentation attached?

NOTE: Maintenance and/or service instructions must include schedules for maintenance and
replacement of those components related to the compliance of the product that may be
expected to be replenished or replaced during the life of the product.

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Page 23

PART 10: INSTRUMENTATION AND CALIBRATION
Describe those tests and controls used to ensure that the reported product will remain in compliance
with the Federal laser product performance standard during its useful life. Items to be addressed
include:
10.1

List the instruments you use to determine compliance of the reported product with the
standard. Describe these instruments or provide copies of specification sheets. Identify each
detector's aperture size, if applicable.

Is additional information attached?

10.2

) Yes

(

) No

Indicate how the measurement system collects or accounts for the total radiant energy or
power specified in Section 1040.10(e).

Is additional information attached?
10.3

(

(

) Yes

(

) No

Provide a measurement error analysis (for all sources of error identified) and an uncertainty
statement for all measurement data reported.

Is additional information attached?

(

) Yes

(

) No

NOTE: If it is clear from the measurement data, including the total estimated
uncertainty, that the levels are well below the applicable class limit, then an error
analysis and uncertainty statement are not required. For, example, an error analysis
and uncertainty statement would not be required for a 1.5 milliwatt HeNe laser product
classified in Class IIIa.

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FORM FDA 3632 (2/14)

Page 24

10.4

Provide instrument calibration schedules and indicate how your instruments are calibrated
(e.g., calibrated by your company against a working standard, returned to the manufacturer
of the instrument, sent to an independent calibration laboratory).

Is additional information attached?

(

) Yes

(

) No

NOTE: If your laser product operates at a level closely approaching a specified limit,
high accuracy and traceability to the National Institute of Standards and Technology
(previously known as the National Bureau of Standards) are important.

Laser Product Report (6/92)
FORM FDA 3632 (2/14)

Page 25