Background
This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of CDRH’s proposed approach on the safety of children’s toy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. 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 children’s toy laser products. FDA recently issued a proposed rule (78 FR 37723) that proposes to define children’s 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 children’s 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This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agency’s proposed approach on children’s toys that are or that contain laser products.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