- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.