BLOG FOR TUESDAY, NOVEMBER 12, 2013 TITLE: Minimizing Risk for Childrens Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Minimizing Risk for Childrens Toy Laser Products. This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Healths (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time. CONTENT: Background This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of CDRHs proposed approach on the safety of childrens toy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. Although Federal law requires all laser products sold in the United States to be in compliance with the Federal Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11), at present FDA regulations do not specifically address childrens toy laser products. FDA recently issued a proposed rule (78 FR 37723) that proposes to define childrens toy laser products and require them to be within International Electrotechnical Commission (IEC) Class 1 emission limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep childrens toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to this vulnerable population. II. Significance of Guidance This draft guidance is being issued consistent with FDAs good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agencys proposed approach on childrens toys that are or that contain laser products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. REFERENCE: Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013); DEPARTMENT OF HEALTH AND HUMAN SERVICES; Food and Drug Administration; Docket No. FDA-2012-D-1092
Posted on: Tue, 12 Nov 2013 17:12:07 +0000
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