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GUIDANCE DOCUMENT

Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) September 1995

Final

Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)

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

This guide was developed by the Office of Compliance, Center for Devices and Radiological Health (CDRH), to assist electronic product manufacturers in providing adequate reporting of radiation safety testing and compliance with performance standards. Reporting requirements are specified in Title 21 of the Code of Federal Regulations (CFR), Part 1002.


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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