FDA 3647 Guide for Preparing Annual Reports on Radiation Safety T

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

FORM FDA 3647 (5/14)
Guide for Preparing Annual Reports on Radiation
Safety Testing of Mercury Vapor Lamps

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 3647 (5/14)

Guide for Preparing
Annual Reports on
Radiation Safety Testing of
Mercury Vapor Lamps

September 1995

For mercury vapor lamp 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 3647 (5/14)

This page is deliberately blank.

FORM FDA 3647 (5/14)

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 3647 (5/14)

NOTE
For mercury vapor lamp manufacturers, this guide replaces the "Guide
for the Filing of Annual Reports (21 CFR Subchapter J, Section
1002.11)," HHS Publication FDA 82-8127. Guides for preparing Annual
Reports on other electronic products are available on request, as
listed below. Call (301) 443-6597 or 1-800-638-2041, or write to the
Division of Small Manufacturers' Assistance (HFZ-220), Center for
Devices and Radiological Health, Rockville, MD 20850.
Guides for Preparing Annual Reports on Radiation Safety Testing of:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.

Television Receivers
Cathode Ray Tubes
Microwave Ovens
Laser and Laser Light Show Products
Mercury Vapor Lamps
Sunlamps and Sunlamp Products
Ultrasonic Therapy Products
Dielectric and Induction Heaters
Diagnostic X-Ray Systems and Major Components
Cabinet X-Ray Systems
Electronic Products (General)
- products intended to produce x radiation (accelerators,
analytical devices, therapy x-ray machines)
- microwave diathermy machines
- cold-cathode discharge tubes
- vacuum switches and tubes operating at or above 15,000
volts

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 3647 (5/14)

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 required 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 for 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 3647 (5/14)

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 black 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,
1993, should cover the reporting year July 1, 1992, through June 30, 1993.
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 number and reported it to you.
"Lamp Family Designation": Indicate the lamp family designation. A lamp
family is a group of one or more mercury vapor lamp models that have
basically similar parameters with regard to the performance requirements
in the standard and that are manufactured using the same or very similar
quality control and testing procedures. Mercury vapor lamp models within
the same family may have different wattage values, different shapes, and
different bases.
"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.
"Lamp Type": Indicate whether the model is Metal Halide Self-Extinguishing
(MHT), Metal Halide Non-Self-Extinguishing (MHR), Mercury Vapor
Self-Extinguishing (HT), or Mercury Vapor Non-Self-Extinguishing (HR).
"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 3647 (5/14)

MERCURY VAPOR LAMP ANNUAL REPORT: Page 1
Report Date:

Part 1. Identification of Manufacturer
Company 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:

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 2.

(

)

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 2.

(

)

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

Lamp
Family
Designation

FORM FDA 3647 (5/14)

Brand

Selling
Model

Lamp
Type

No. of
DisconUnits
Plant
tinued
Produced Location (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 Initial or Model Change Reports should be reviewed
and updated.

Compare your current procedures with those submitted in your Initial or
Model Change 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) and (3) to maintain results
of quality control tests and life 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 1040.30). Summarize the results of these tests by
completing the table, or provide comparable data on a separate sheet and
label it Part 5.

"Type of Test": On each line of the table, indicate which type of test was
conducted, using these codes:
(Q)
(L)

= quality control test
= life test

"Labeling Check": Complete this column only for quality control tests.
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.

FORM FDA 3647 (5/14)

MERCURY VAPOR LAMP 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
No. of Units
Tested
Model
No.

Type of
Test

"T"

"R"

Extinguishing Time
Mean

Std.
Dev.

No. of Lots
Failed

Labeling Check
(No. of Lots)
Pass

Fail

Part 6. Correspondence Concerning Radiation Safety
The number of letters received from users, dealers, or others about
possible radiation exposure or safety-related failures during use of the
product was
.
Attach a copy of each letter.
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.

FORM FDA 3647 (5/14)