- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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-2014-D-0435.