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GUIDANCE DOCUMENT

Surveying, Leveling, and Alignment Laser Products Guidance for Industry and Food and Drug Administration Staff January 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0435
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to outline, for manufacturers, the FDA’s approach regarding the applicability of FDA’s performance standard regulations to surveying, leveling, and alignment (SLA) laser products to help manufacturers with questions they have raised.  This guidance addresses topics including considerations for what is an SLA laser product, examples of SLA and non-SLA laser products, and information on variances and exemptions from SLA laser product class limits.

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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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0435.

 
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