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GUIDANCE DOCUMENT

User Instruction Hazard Warnings (Laser Notice 35) February 1985

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

To: All Manufacturers and Potential Manufacturers of Laser Products
Subject: Reproduction of Hazard Warnings in User Instructions


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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:

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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.