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Changes to TV Annual Report Guide Regarding Radiation SafetyMay 14, 1997
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.
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:
7.6 Model/Brand listing new table By Factory:
* = M (monitor); P (projector); R (receiver);V (viewfinder); O (other, specify) 7.7 Life Testing revised questions:
Updated December 29, 2006 |
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