- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
The purpose of this memorandum is to notify all laser product manufacturers of an exemption granted for all laser products which are manufactured after August 2, 1976, and used exclusively by DOD agencies, and which are designed for actual combat or combat training operations or are classified in the interest of national defense (Reference FDA Docket No. 76P-0335). The exemption does not apply to laser products intended primarily for use in indoor classroom training and demonstration, industrial operations, and scientific investigations; and medical laser products. The exemption is from the FDA performance standard for laser products in 21 CFR Part 1040.10 and 1040.11 and the associated reporting and record keeping requirements of 21 CPR 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.