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Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) September 1979

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this memorandum is to notify all laser product manufacturers of exemptions granted for laser products intended for U.S. Government use (21 CFR 1010.5).  These laser products may not be the same as models that are certified and sold or leased commercially. They are to be used exclusively by (1) the National Oceanic and Atmospheric Administration, U.S. Department of Commerce or by (2) the Department of Energy or by its contractors at DOE designated, government-owned contractor-operated (GOCO) facilities in unique research applications or as components in larger research and development systems. The exemption is from the FDA performance standard for laser products, 21 CFR 1040.10 and 1040.11, and the associated reporting and recordkeeping requirements, 21 CFR Part 1002, except for paragraph 1002.20 relating to accidental radiation occurrences.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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