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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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