Guide for Preparing

Annual Reports on

Radiation Safety Testing of

Laser and Laser Light Show

Products

September 1995

(Address corrections Aug. 2008)

For laser product manufacturers, this guide replaces FDA 82-8127

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration

Center for Devices and Radiological Health

Rockville, Maryland 20857

Foreword

This guide was developed by the Office of Compliance, Center for Devices
and Radiological Health (CDRH), to assist electronic product
manufacturers in providing adequate reporting of radiation safety
testing and compliance with performance standards. Reporting
requirements are specified in Title 21 of the Code of Federal
Regulations (CFR), Part 1002.

Reports submitted on radiation safety of electronic products must follow
the appropriate guide (21 CFR 1002.7), or contain a justification why it
was not followed. CDRH may reject an incomplete report and return it for
completion. When the report is adequate for filing, it will be logged
into the CDRH computer system and assigned an accession number. 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.

WE DO NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED. It is
the manufacturer\'s responsibility to certify that their products comply
with the applicable standard (21 CFR 1010 - 1050), based on a testing
program in accordance with good manufacturing practices. The
manufacturer is required to submit the report (21 CFR 1002) and to
comply with all applicable importation requirements (21 CFR 1005) prior
to the shipment of products in interstate commerce. If there are
deficiencies, we may disapprove the firm\'s quality control and testing
program or determine that the product contains a radiation defect or
fails to comply with a standard. We will notify the manufacturer if we
make such a determination. Then the manufacturer may be required 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.

We are making our reporting guides available on the CDRH web site at
http://www.fda.gov/cdrh/comp/eprc.html, for downloading and
reproduction. They are not copyrighted and may be reproduced as needed.

Please mail your reports to the address below (electronic submissions
cannot be processed yet). Provide one original IN ENGLISH (no facsimile,
please) unless specified otherwise in the guide. Make a copy of the
completed report for your records. If you would like to comment on the
reporting guides or the electronic docket or future electronic
submissions, you may direct the comments to the same address. If you
need additional regulations for electronic products or medical devices,
contact the Division of Small Manufacturers, International, and Consumer
Assistance by telephone at 1-800-638-2041 or 301-443-6597, or by
facsimile at 301-443-8818.

Lillian J. Gill

![](media/image1.png){width="2.345833333333333in"
height="0.6298611111111111in"}

Director

Office of Compliance

MAILING ADDRESS:

Center for Devices and Radiological Health

ATTN: Electronic Product Reports

Electronic Product Document Control (HFZ-309)

Office of Communication, Education, and Radiation Programs

9200 Corporate Blvd.

Rockville, MD 20850

NOTE

For laser and laser light show product manufacturers, this guide
replaces the \"Guide for the Filing of Annual Reports,\" 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,
International, and Consumer Assistance (HFZ‑220), Center for Devices and
Radiological Health, Rockville, MD 20850.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

PREFACE

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.

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.

In addition, the Annual Report is the appropriate vehicle for
identifying new models for which Supplemental Reports are not required.
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 submitted prior to October 1, December 1, March 1,
and/or June 1 when required, referencing the previous Annual Report.
\[See 21 CFR 1002.13(c).\]

Questions about reporting and suggestions for changes to this guide may
be sent to the above address or may be discussed by calling the
Electronic Products Branch at 240-276-3332.

INSTRUCTIONS: Page 1

General

For ease in photocopying, all instructions are on the left-hand pages
while the corresponding forms are on the right-hand pages. You need only
submit the completed forms and any additional information you have
provided on separate sheets. On all separate sheets or attachments be
sure to 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 computer,
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.

LASER PRODUCT/LASER LIGHT SHOW ANNUAL REPORT: Page 1

Part 1. Identification of Manufacturer Report Date:

Company Name:

Address:

Corresponding Official signature:

Name & title:

Telephone:

Firm name & address, if different from above:

This Annual Report is submitted in accordance with 21 CFR 1002 for the
period July 1, 19 through June 30, 19 .

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 4.

( )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
4.

( )Products were manufactured during this period but the firm is now out
of business. IF YOU CHECK THIS, COMPLETE AND MAIL THIS ENTIRE REPORT.

INSTRUCTIONS: Page 2

Part 3. Current Production Tabulation

Provide production data, using the forms or comparable tabulations.
Complete Part 3.1 for all laser products. For laser light shows, also
complete Part 3.2. If additional space is needed, use another copy of
the form(s) or attach separate sheet(s) labeled Part 3.

3.1. All Laser Products

\"Accession Number\": For previously reported models, CDRH will have
assigned this reference number and reported it to you. New Class I
models that satisfy the exemption criteria given in the Laser Notices to
Industry dated August 23, 1985, and August 9, 1988, should be listed
under the initial product report for that family of products. Other
models that satisfy the post-market reporting criteria in section
1002.13(c) should be listed under the model family report as well.

\"Family Designation\": A model family consists of more than one model
essentially identical in application, design, and performance.

\"Product Function\": Indicate the primary application of each model,
e.g., cutting; trimming; welding; surgery; alignment; surveying.

\"Class\": Give the laser product class of each model listed.

\"Production Status (Active)\": If the model is currently being
manufactured, place an \"X\" in this column.

\"Production Status (Discontinued)\": Provide discontinuation date
(month and year) for any model that is no longer in production but was
produced at some time during the reporting period.

\"Production Status (Plant)\": Codes may be used for each plant location
if you provide the codes and complete address for each manufacturing
location on a separate sheet, labeled Part 3.

3.2. Laser Light Shows

\"Permanent or touring\": Indicate type of use environment. For multiple
performances at a fixed location, such as at a planetarium, indicate
(permanent). For one or more performances at multiple locations,
indicate (touring).

\"Production Status (Number of Shows Performed)\": Give separate figures
for touring and permanent performances.

LASER PRODUCT/LASER LIGHT SHOW ANNUAL REPORT: Page 2

Part 3. Current Production Tabulation

3.1. All Laser Products

+-------+--------+---------+----------+------+-------+--------+------+
| Acce  | Family | Selling | Product  | C    | Produ |        |      |
| ssion | Desig  | Model   |          | lass | ction |        |      |
| N     | nation | Numbers | Function |      | S     |        |      |
| umber |        |         |          |      | tatus |        |      |
+-------+--------+---------+----------+------+-------+--------+------+
|       |        |         |          |      | A     | Di     | P    |
|       |        |         |          |      | ctive | scont. | lant |
|       |        |         |          |      |       | (      |      |
|       |        |         |          |      |       | mo/yr) |      |
+-------+--------+---------+----------+------+-------+--------+------+
|       |        |         |          |      |       |        |      |
+-------+--------+---------+----------+------+-------+--------+------+

3.2. Laser Light Shows

+----------+-------------+---------+------+------+----------+--------+
| A        | Projector   | Pe      | C    | La   | Pr       |        |
| ccession | or Show     | rmanent | lass | sing | oduction |        |
| Number   | Family      | or      |      | M    | status   |        |
|          | Designation | Touring |      | edia |          |        |
+----------+-------------+---------+------+------+----------+--------+
|          |             |         |      |      | No.      | Di     |
|          |             |         |      |      | Shows    | scont. |
|          |             |         |      |      | P        |        |
|          |             |         |      |      | erformed | (      |
|          |             |         |      |      |          | mo/yr) |
+----------+-------------+---------+------+------+----------+--------+
|          |             |         |      |      |          |        |
+----------+-------------+---------+------+------+----------+--------+

INSTRUCTIONS: Page 3

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 Laser Product Reports should be reviewed and
updated.

Compare your current procedures with those submitted in your Laser
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
1040.10 and 1040.11).

Complete Part 5 for all laser products and/or laser light shows. For
each model or show produced, review your quality control records and
indicate the number of units or shows that were tested for performance
requirements, labels, and light show variance conditions, if applicable.

LASER PRODUCT/LASER LIGHT SHOW ANNUAL REPORT: Page 3

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

  ----------------------- ---------- -------------- -------- ----------------
  Model Number or Name of Number     Number Tested           
  Show                    Produced                           

                                     Performance    Labels   Light Show
                                     Requirements            Variance
                                                             Conditions

                                                             
  ----------------------- ---------- -------------- -------- ----------------

INSTRUCTIONS: Page 4

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.

LASER PRODUCT/LASER LIGHT SHOW ANNUAL REPORT: Page 4

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:

( ) A COPY OF EACH LETTER IS ATTACHED.

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:

( ) A SUMMARY OR ( ) A SAMPLE OF CORRESPONDENCE IS ATTACHED. 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:

( ) A SUMMARY OR ( ) A SAMPLE OF CORRESPONDENCE IS ATTACHED.

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: