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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Changes to TV Annual Report Guide Regarding Radiation Safety

May 14, 1997

TO: Manufacturers and Importers of Television Products
 
SUBJECT: Changes to TV Annual Reports (21 CFR 1002.13)

ISSUE

The Consumer Electronics Manufacturers Association (CEMA), a sector of the Electronic Industries Association, has requested that the Food and Drug Administration(FDA), Center for Devices and Radiological Health (CDRH), modify the annual report guide for television products.

BACKGROUND

Manufacturers of electronic products are required to submit radiation safety reports under Section 537(b) of the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the Radiation Control for Health and Safety Act of 1968). Information submitted must conform to CDRH guides or instructions when they exist (21 CFR 1002.7). The latest reporting guide for television products is dated October 1995.

By letter dated May 9, 1996, CEMA asked that information on testing of television products be summarized by plant and chassis family rather than by individual model as currently requested. The change is expected to reduce tracking resources and paperwork burden on industry, without impact on FDA or public health.

GUIDANCE

CDRH concurs with the CEMA suggestion and is revising the reporting guide for television products accordingly. Revised tables and questions for sections 7.5, 7.6, and 7.7 are enclosed. They may be used now for preparing new annual reports.

In accordance with FDA's Good Guidance Practices, comments are invited. This guidance document represents the agency's current thinking on annual reporting of television products. It does not create or confer any right 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 and/or regulations.

Any comments or questions should be directed to the Electronic Products Branch at the address above, by telephone at 301-594-4654 or by facsimile at 301-594-4672.

 

 

 

 

 

Sincerely yours,

 

 

 

 

 

Lillian J. Gill
Director
Office of Compliance
Center for Devices and
  Radiological Health

 



Changes to Annual Reporting Guide for Television Products
     (7.5 Current Production & 7.6 Test Results to be combined)

7.5 Current Production and Test Results ­ new table

By Factory:

 

Product Report
Accession
Number
Chassis
Family
Quantity
Produced
Number
Tested
Maximum
Radiation
Number of
sets/lots
Rejected

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7.6 Model/Brand listing ­ new table

By Factory:

 

Accession No. or
Chassis Family
 Model No.   Brand   Product
Type *
Screen
Size

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    *  =   M (monitor); P (projector); R (receiver);V (viewfinder); O (other, specify)

7.7 Life Testing ­ revised questions:

 

  7.7.1 How many sets were life tested?
  7.7.2 Were there any life test failures?
If so, specify which chassis was involved,
what the failure was, and the correcive actions taken.