FDA 3631 Guide for Preparing Annual Reports on Radiation Safety T

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

FORM FDA 3631 (2/14)
Guide for Preparing Annual Reports on
Radiation Safety Testing of Sunlamp Products

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
[email protected]
*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 3631 (2/14)

GUIDE FOR PREPARING
ANNUAL REPORTS ON
RADIATION SAFETY TESTING OF
SUNLAMP PRODUCTS

SEPTEMBER 1995

For sunlamp product manufacturers, this guide replaces FDA 82-8127.

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

FORM FDA 3631 (2/14)

This page is deliberately blank.

FORM FDA 3631 (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: [email protected]
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 3631 (2/14)

TO: All Electronic Product Manufacturers Subject to Annual Reporting Requirements of 21 CFR 1002.11,
Pursuant to the “Federal Food, Drug, and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product
Radiation Control.”
SUBJECT: Filing of Annual Reports on Radiation Safety Testing
The Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control
directs the Department of Health and Human Services to evaluate testing programs carried out by industry to
assure the adequacy of safeguards against hazardous electronic product radiation and to assure that products
comply with performance standards. This Act also requires that manufacturers of electronic products establish
and maintain records and provide performance data on radiation safety and information on their testing
programs.
In order to carry out its responsibilities under the FFDCA, the Food and Drug Administration’s Center for
Devices and Radiological Health, CDRH, has issued a series of regulations contained in Title 21 of the Code of
Federal Regulations, CFR. Part 1002 of 21 CFR deals with records and reports. Section 1002.61 categorizes
electronic products into Groups A through C. Section 1002.30 requires manufacturers of products in Groups B
and C to establish and maintain certain records, while Section 1002.13 requires such manufacturers to submit
an Annual Report summarizing the contents of the required records. Section 1002.7 requires that reports
conform to reporting guides issued by CDRH unless an acceptable justification for an alternate format is
provided.
SAVE THIS REPORTING GUIDE AND USE IT EACH YEAR. When a revision is issued, you will be sent a
copy. You must submit your Annual Report by September 1 of each year unless you have received a letter of
exemption from CDRH under 21 CFR 1002.50. You should duplicate the forms in this guide for inclusion in your
report and retain a copy for your records. Proprietary information should be specifically and clearly marked.
Information submitted in your report will be used to evaluate your testing program, identify safety problems, and
make decisions on the level and type of monitoring programs to be conducted by FDA, such as product testing
and factory inspections.
Upon receipt of your Annual Report, CDRH will send you an acknowledgment letter with an accession number
you should reference whenever you submit additional information.You will receive further notification only if
additional information or clarification is needed.
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 3631 (2/14)

REMINDER
ACCIDENTAL RADIATION OCCURRENCES
You are required by 21 CFR Subchapter J. Section 1002.20 to immediately report accidental
radiation occurrences. Report to the Director, Center for Devices and Radiological Health, all
accidental radiation occurrences reported or otherwise known to you and arising from the
manufacture, testing or use of any product you have introduced, or intend to introduce, into
commerce.

FORM FDA 3631 (2/14)

INSTRUCTIONS: Page 1
General
For ease of photocopying, all instructions are on the left-hand pages while the corresponding forms are on
the right-hand pages. You need to submit only the completed forms and any information you have provided
on separate sheets. If you use separate sheets or additional copies of the forms, label each page with
sequential lettering. Example: Page 3a, Page 3b, Page 3c.
The forms provide blanks to be filled in, boxes ( ) to be checked, and tables or graphs to be completed.
They may be prepared with a typewriter or hand-printed in blank ink.
Part 1. Identification of Manufacturer
Fill in the requested information and sign where indicated. Fill in the years in the reporting period.
Example: The report due on September 1, 1991, should cover the reporting year July 1, 2010, through June
30, 2011.

Part 2. Production Status
Check the statement that applies to your firm and take the indicated action.

Part 3. Current Production Tabulation
Provide production data, using the form or a comparable tabulation. If additional space is needed, use
another copy of the form or attach a separate sheet and label it Part 3.
“Accession No.”: For previously reported models, CDRH will have assigned this unique reference number
and reported it to you.
“Brand”: You may use a code for each brand in the chart. On a separate sheet, provide the
complete address for each importer or distributor of each brand and identify any codes. Label the sheet
Part 3.
“Type”: Indicate whether the model is Lamp Only UVA (LA), Lamp Only UVB (LB), Home Portable
UVA (PA). Home Portable UVB (PB), Booth UVA (BA), Booth UVB (BB), Booth UVA and UVB (BC), Couch
Bed UVA (CA), Couch and Top UVA (CTA), or Other (0). If (0) is indicated, provide a description on a
separate sheet labeled Part 3.
“Plant Location”: Codes may be used. On a separate sheet, provide the complete address for each
manufacturing location and identify any codes. Label the sheet Part 3.
“Discontinued (mo/yr)”: Provide discontinuation date for any model that is no longer in production but was
produced at some time during the reporting period.

FORM FDA 3631 (2/14)

SUNLAMP PRODUCT ANNUAL REPORT: Page 1
Part 1. Identification of Manufacturer

Report Date:

Corporate Name:
Address:

This Annual Report is submitted in accordance with 21 CFR 1002.11 for the
.
period July 1, 20
through June 30, 20
Corresponding Official (signature):
Name & title:
Telephone number:

Email address:

Part 2. Production Status
( ) Products were manufactured during this period and the firm is still in business. If you check this,
complete and mail this entire report.
( ) No products were manufactured during this period but the firm is still in business and expects to
manufacture in the future. If you check this, complete Part 6 and mail pages 1 and 3.
( ) No products were manufactured during this period and the firm is now out of business. If you
check this, complete Part 6 and mail pages 1 and 3.
( ) Products were manufactured during this period but the firm is now out of business. If you check
this, complete and mail this entire report.

Part 3. Current Production Tabulation

Accession
Number

FORM FDA 3631 (2/14)

Model

Brand

Type

Plant
Location

No. Units
Produced

Discontinued
(mo/yr)

INSTRUCTIONS: Page 2
Part 4. Procedures for Quality Control and Testing
You are required by 21 CFR 1002.30(a)(1) and (2) to maintain written procedures for quality control
and testing. The procedures in use and those submitted in the Product Reports should be reviewed
and updated. Compare your current procedures with those submitted in your Product Reports. Check
the appropriate answers and take any indicated action.
Part 5. Summary of Test Results
You are required by 21 CFR 1002.30(a)(2) to maintain results of quality control tests. For each
product introduced into commerce, you should evaluate test results to be certain that the total program
is adequate to assure radiation safety and compliance with the standard (21 CFR 1040.20).
5.1 Results of Final Product Tests
Complete the table or provide comparable data on a separate sheet and label it Part 5.1.
“Irradiance Ratio Maximum”: Indicate the maximum irradiance ratio UVC/UVB for the sunlamps or
sunlamp products, where 180 nm < UVC ≤ 260 nm and 260 nm < UVB ≤ 320 nm.
“Max. Time Error”: Indicate the maximum error (in percent) of all times measured at the maximum
timer setting.
“Protective Eyewear Transmittance”: Provide transmittance data for three wavelength ranges.
T1 (180 nm < wavelength ≤ 320 nm): Indicate maximum measured value.
T2 (320 nm < wavelength ≤ 360 nm): Indicate maximum measured value.
T3 (wavelength > 360 nm): Is the transmittance sufficient to allow the user to read the labels and
reset the timer? Indicate (Y) yes or (N) no.
If transmittance measurements are not conducted, provide (on a separate sheet labeled 5.1) an
explanation of why they are not needed and the model number and manufacturer’s name for the
protective eyewear.

FORM FDA 3631 (2/14)

SUNLAMP PRODUCT ANNUAL REPORT: Page 2
Part 4. Procedures for Quality Control and Testing
The written procedures for assessing and controlling radiation safety have been reviewed. (These
include prototype testing, incoming materials testing, assembly testing, retesting after repair, and
service testing). The procedures for maintaining quality control testing equipment have also been
reviewed. All procedures are up-to-date, complete, and accurate.
( ) YES (
) NO
The reports provided to CDRH for each model family currently in production have been reviewed and
the procedures contained in them are up-to-date, complete, and accurate.
( ) YES ( ) NO
If you answered no to either question, provide the current procedures in a supplement to the
appropriate model family report.

Part 5. Summary of Test Results
5.1. Results of Final Product Tests

Number of Units Tested
Model

Irradiance

Timer

Eyewear

Irrad.
Ratio
(Max.)

Max.
Timer
Error
(%)

Protective Eyewear
Transmittance
T1
(%)

T2
(%)

T3
(%)

Adeq.
Vis.
(Y/N)

If necessary, use an additional sheet of paper to display other models and their final test results.

FORM FDA 3631 (2/14)

INSTRUCTIONS: Page 3
5.2 Results of Life Tests
You are required by 21 CFR 1002.30(a)(3) to maintain results of life tests. Summarize tests on
prototypes and on final products to show how extended use can affect radiation safety, or provide
comparable data on a separate sheet and label it Part 5.2.
“Number Tested”: Indicate how many units were tested.
“Max. Irrad. Ratio”: Indicate the results of irradiance ratio tests. Use column (W) for results of tests
performed with UV filter/absorbers used in the product (if any) and/or use column (W/O) for test results
with no filters. Products that use filter/absorbers should be tested both with and without them. For
each model, indicate the maximum irradiance ratio for all units at the beginning (Beg) of the test and
also at the end. In order to fit data in the column width provided, you may want to use scientific
notation and place the power of 10 on the second line.
“Timer”: Indicate the number of cycles, number of failures, and the maximum timer errors (Max. Er (%))
measured at the maximum timer setting at the beginning (Beg) and the end of the test. On a separate
sheet, describe the types of timer failure, e.g., failure to turn on, failure to turn off, or intermittent on
and off problem. Label the sheet Part 5.2.
“Eyewear Transmit”: Indicate the maximum transmittance values for the three wavelength ranges at
the beginning of the test and also at the end. In the “Code” column, indicate (B) for beginning and (E)
for end. (See Part 5.1, “Protective Eyewear Transmittance,” for definitions of ranges.)
Part 6. Correspondence Concerning Radiation Safety
You are required by 21 CFR 1002.30(a)(4) to maintain copies of communications to or from dealers,
distributors, and purchasers concerning radiation safety. Correspondence should be reviewed if it
involves any of the following complaints or concerns about radiation exposure; difficulties with safety
components in use or servicing of the product, investigations made or instructions issued concerning
use, adjustment, and repair.
Fill in the number of documents sent or received and attach the copies, summaries, or samples as
indicated.
NOTE: This summary does not replace the notification requirements for potential defects or
noncompliances under 21 CFR 1003.10 or for suspected accidental radiation occurrences under 21
CFR 1002.20.
Part 7. Distribution Records
You are required by 21 CFR 1002.30(b)(1) and (2) to maintain distribution records. Such records must
allow tracing of products to the dealer and, if possible, to the user. Fill in the information on the
location of records storage and check the means of tracing products.

FORM FDA 3631 (2/14)

SUNLAMP PRODUCT ANNUAL REPORT: Page 3
5.2 Results of Life Tests
Max. Irrad. Ratio

Model
No.

Test
Length
(hr)

W
Number
Tested

B

Timer

W/O
E

B

E

Eyewear Transmitance
Max. Er.
(%)

No.
Cycle

No.
Fail

B

E

Max. Value (%)
Code
(B/E)

T1

T2

T3

Adeq.
Vis.
(Y/N)

If necessary, use an additional sheet of paper to display other models and their final test results.
Part 6. Correspondence Concerning Radiation Safety
The number of letters received from users, dealers, or others about possible radiation exposure or
timer failures during use of the product was
.
Attach a copy of each letter.
The number of letters received from dealers, distributors, or others concerning the need for repair,
adjustment, or replacement of a part to maintain radiation safety of the product was
.
Attach a summary of correspondence or a sample. Identify any trends in failed components or
adjustments needed during servicing.
The number of notices or brochures sent to users, dealers, or service personnel on precautions or
actions to be taken to maintain radiation safety of the product was
.
Attach a summary of correspondence or a sample.
Part 7. Distribution Records
Production facility shipping records and dealer records (when returned) are maintained at:
.
Products can be traced from these records by:
(
(
(
(

) Model
) Serial Number
) Date of Manufacture
) Other, specify:

FORM FDA 3631 (2/14)

.