FDA 3638 Guide for Filing Annual Reports for X-Ray Components and

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

FORM FDA 3638 (3/14)
Guide for Filing Annual Reports for X-Ray
Components and Systems

Public reporting burden for this collection of information is estimated to average 26.5 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 3638 (3/14)

HHS Publication FDA 890-8123

Guide for Filing
Annual Reports
for X-Ray Components
and Systems
Office of Compliance

July 1980
(Reprinted April 1987)

The reporting and/or recordkeeping requirements contained herein
have been approved by the Office of Management and Budget in
accordance with the Paperwork Reduction Act.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Silver Spring, MD 20993

FORM FDA 3638 (3/14)

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FORM FDA 3638 (3/14)

CONTENTS
Page
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.1 PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.2 APPLICABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.3 REPORT DATE AND REPORT PERIOD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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1.4 ADDITIONAL GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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CURRENT PRODUCTION TABULATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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2.1 DISCONTINUED COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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2.2 ADDED COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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SUMMARY OF RECORDS TO BE MAINTAINED BY MANUFACTURERS . . . . . . . . . . . . . . . . . .

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3.1 RESULTS OF TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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3.2 RESULTS OF LIFE (RELIAB ILITY) TESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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3.3 CORRESPONDENCE AND OTHER WRITTEN COMMUNICATIONS . . . . . . . . . . . . . . . . . . .

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APPENDIX A. ADDITIONAL GUIDANCE FOR CABINET X-RAY SYSTEMS . . . . . . . . . . . . . . . . . . . .

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1.0

2.0

3.0

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FORM FDA 3638 (3/14)

GUIDE FOR FILING ANNUAL REPORTS FOR X-RAY COMPONENTS AND SYSTEMS
1.0 INTRODUCTION
1.1 PURPOSE
This document will serve as a guide for all x-ray component manufacturers in complying with 21
CFR Subchapter J regarding Annual Reports.
1.2 APPLICABILITY
This guide is applicable to every x-ray component manufacturer subject to the provisions of 21
CFR 1002.13, Annual Reports.
1.3 REPORT DATE AND REPORT PERIOD
Annual Reports shall be submitted by September 1 of each year. Such reports should cover the
12-month period ending on June 30, preceding the date of the report.
1.4 ADDITIONAL GUIDANCE
A response is required for each paragraph of the guide. If the paragraph does not apply, write "Not
Applicable."
2.0 CURRENT PRODUCTION TABULATION
2.1 DISCONTINUED COMPONENTS
Please list all components discontinued during the reporting year. Include model number and date
of discontinuation.
2.2 ADDED COMPONENTS
Please list all certified components introduced during the reporting year. Include model number,
place of manufacture, and the CDRH Accession Numbers assigned to the initial or supplemental
reports in which the corresponding components were reported.

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FORM FDA 3638 (3/14)

3.0 SUMMARY OF RECORDS TO BE MAINTAINED BY MANUFACTURERS
The following definitions apply to Section 3.0:
(1) Direct Test – one that actually measures the compliance parameter of interest.
(2) Indirect Test – one that measures a parameter that can be correlated to the compliance parameter of
interest.
(3) Go/No-Go Test – one in which no data are generated or recorded, and the tester makes the
rejection/acceptance decision based on predetermined written criteria.
(4) Name of Test – identification of the requirement in the Performance Standard being tested.
3.1 RESULTS OF TESTS
NOTE: Any corrections, changes, modifications or additions to those test procedures that were
previously reported in Initial Report(s) should be submitted to the Center for Devices and
Radiological Health as supplements to the appropriate Initial Report.
For each direct or indirect test described in your Initial Report(s) (and/or supplements) and performed
to determine compliance of the components, provide a summary of the test date for each model (or
group of models with similar design and testing) using one of the following two methods:
a.

Go/No-Go
(1) Name of Test:
(2) Rejection Limit:
(3) Component Model Number(s):
(4) Percent of Components Tested:
(5) Number of Components Rejected:

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FORM FDA 3638 (3/14)

b.

Histogram

For all test summaries other than those presented in Go/No-Go form, provide the following information
and a histogram displaying the number of components tested versus the test parameter value.
(1) Name of Test:
(2) Rejection Limit:
(3) Component Model Number(s):
(4) Percent of Production Tested:
Example of histogram:

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FORM FDA 3638 (3/14)

3.2 RESULTS OF LIFE (RELIABILITY) TESTS
The Center for Devices and Radiological Health's concern with compliance-related reliability tests
relates to the impact of these tests on maintenance schedules provided to the users.
For any compliance related life (reliability) tests performed (or monitored on an ongoing basis)
during the reporting year, provide the following:
a.

Name of Test:

b.

Identification of component tested:

c.

Number of components tested:

d.

Time to failure or number of cycles to failure for each component tested:

(Note: "Failure" means the component tested is no longer in compliance.)
e.

Describe how the time to failure or cycles to failure information is factored into the
maintenance schedules to users.

3.3 CORRESPONDENCE AND OTHER WRITTEN COMMUNICATIONS
Federal regulations require that files be maintained with copies of all written communications
between the manufacturer and dealers, distributors, and purchasers concerning radiation safety
complaints, investigations, instructions, or explanations affecting the use, repair, adjustment,
maintenance, or testing of the listed component.
Additionally, a March 8, 1978 letter to all manufacturers urged each manufacturer to develop and
utilize a system of obtaining and analyzing all causes of defects and failures to comply with the
Standard.
Provide the following:
a.

A brief description of the system used to obtain and analyze all causes of defects and failures
to comply with the Standard.

b.

A summary (or copies) of all written communications, both incoming and out-going, relating
to these causes of defects and noncompliances.

c.

A summary or copies of any other written communications relating to electronic product
radiation safety.

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FORM FDA 3638 (3/14)

APPENDIX A
ADDITIONAL GUIDANCE FOR CABINET X-RAY SYSTEMS

The following guidance for cabinet x-ray systems is provided in addition to the general guidance in Paragraphs
1.0 - 3.0.
A. Provide a summary of records pertaining to service and maintenance affecting radiation safety
performance.
B. Provide a summary of radiation surveys performed in the field.

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FORM FDA 3638 (3/14)