FDA > CDRH > Radiological Health Program > Products and Procedures > Televisions and Video Display Monitors > Exclusion from Radiation Standard for Camcorder Viewfinders

Exclusion from Radiation Standard for Camcorder Viewfinders

May 14, 1997

TO:	Manufacturers and Importers of Television Products
SUBJECT:	Exclusion from the Radiation Performance Standard (21 CFR 1020.10) for Camcorder Viewfinders

ISSUE

The Consumer Electronics Manufacturers Association has requested that the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), exempt low voltage television products, especially camcorder viewfinders, from the Performance Standard for Televisions Receivers, 21 CFR 1020.10.

BACKGROUND

Electronic products distributed in U.S. commerce are required to meet applicable radiation safety performance standards promulgated under Section 534 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). Manufacturers must certify each product to be in compliance with applicable standards.

On March 7, 1996, the Consumer Electronics Manufacturers Association (CEMA), a sector of the Electronic Industries Association, requested that television products operating at less than 5 kilovolts (kV) be exempt from the standard, 21 CFR 1020.10. CEMA asks that these low voltage products, especially camcorder viewfinders, be exempt because there is little likelihood of producing or emitting x-rays. The change is expected to reduce the regulatory burden on industry, with negligible impact on public health.

The CDRH recognizes that the likelihood of x-ray production from low voltage products is small. An exclusion from the performance standard is appropriate for camcorder viewfinders since there is sufficient information on the product technology to confirm the unlikely production of radiation from such products. However, in the absence of data regarding new technologies, failure modes, and voltage levels under worst-case conditions, additional exclusions should be limited at this time.

GUIDANCE

CDRH considers the Performance Standard for Television Receivers (21 CFR 1020.10) not applicable to camcorder viewfinders; therefore they are not subject to requirements for certification (21 CFR 1010.10(a)), identification (21 CFR 1010.10(b)), and importation declaration (21 CFR 1005 and Form FDA 2877) under the following conditions:

1. The camcorder viewfinders must not operate at voltages greater than 5 kilovolts (kV) under any conditions of component failure.
2. Manufacturers must document conformance with the first condition in the abbreviated report on the chassis family (21 CFR 1002.12). Any suspect   accidental radiation occurrences must be reported in accordance with 21 CFR 1002.20.

In accordance with FDA's Good Guidance Practices, comments are invited. This guidance document represents the agency's current thinking on the applicability of the television performance standard to camcorder viewfinders. 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

Updated December 29, 2006