- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
The 1985 amendments to the Federal Performance Standard for Laser Products gave the Director, Office of Compliance and Surveillance, Center for Devices and Radiological Health (CDRH) authority to approve, upon written application by the manufacturer, alternate means to accomplish the radiation protection provided by the beam attenuator (21 CFR 1040.10(f) (6) (ii)). This amendment recognized that for many laser products, a beam attenuator, usually a shutter, provides little if any improved safety, especially for laser system that have short beam.
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.