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GUIDANCE DOCUMENT

Manufacture and Certification of Laser Kits (Laser Notice 13) October 1976

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

To: All Manufacturers and Potential Manufacturers of Laser Products

SUBJECT: Manufacture and Certification of Laser Kits, 21 CFR 1040.10 and 1010.2


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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