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GUIDANCE DOCUMENT

Investigational Medical Laser Significant Risk Device (Laser Notice 31) May 1981

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guide provides: Criteria for Considering an Investigational Medical Laser Device as a Significant Risk Device


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.