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FDA ISSUES GUIDANCE ON CHILDREN’S TOY LASER PRODUCTS

Toys are subject to numerous safety standards, including FDA regulations related to the use of lasers. Most “laser-like” toys on the market employ harmless LED lights to simulate lasers; any toy that uses actual laser technology and falls under current FDA definitions for laser products must comply with FDA rules for low power lasers. 

Currently, FDA regulations do not address toy laser products specifically manufactured, designed, intended or promoted for use by children under 14 years of age. However, as previously reported, in June 2013 the CDRH proposed changes to its laser regulations with a draft rule defining children’s toy laser products and requiring them to be within the International Electrotechnical Commission (IEC) Class 1 emission limits.

While this rulemaking process is ongoing, the FDA’s guidance recommends that manufacturers producing children’s laser products meet the current FDA Class 1 or IEC Class 1 emission limits, in order to “minimize the risk they pose to users and/or others in range of the laser beam.” Though the guidance is non-binding, the FDA could initiate enforcement action against products that do not comply with the recommendations.

The Toy Industry Association (TIA) previously submitted comments on behalf of the toy industry regarding the proposed rule, supporting the FDA’s attempt to align with EU and IEC limits, but suggesting changes to the proposed definition and asking that a more recent version of the IEC standard be utilized as a model.

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