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GUIDANCE DOCUMENT

Minimizing Risk for Children's Toy Laser Products Guidance for Industry and Food and Drug Administration Staff December 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-1092
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance is intended to inform manufacturers of laser products, FDA staff and the public of the Center for Devices and Radiological Health’s (CDRH) current thinking on the safety of children’s toy laser products. Lasers with outputs above certain levels that are operated in an unsafe and uncontrolled manner may cause injury to the user and/or others within range of the laser beam. This is a particular concern for lasers intended for entertainment purposes, especially when intended to be used as toys by children.

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Submit Comments Online

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:

Dockets Management
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-2012-D-1092.

 
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