Print PDF

Practice Areas

FDA Issues Guidance on Children’s Toy Laser Products

Friday, December 19, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued a guidance document intended to inform manufacturers of laser products, FDA headquarters and field personnel, and other interested parties of the Center for Devices and Radiological Health’s current thinking on the safety of children’s toy laser products. The document also provides specific safety recommendations for the manufacture and labeling of these items.

FDA notes that 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. Federal law generally requires laser products manufactured or assembled after Aug. 1, 1976, to be in compliance with the federal performance standards for laser products. While federal regulations do not specifically identify what constitutes a children’s toy laser product, FDA issued a proposal in June 2013 to define such products and require them to be within the International Electrotechnical Commission Class 1 emission limit.

While this rulemaking process is still ongoing, CDRH recommends that manufacturers keep children’s toy laser products within the FDA Class I 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, including the vulnerable population for whom they are intended. For those children’s toy laser products that meet the definition of a “demonstration laser product” or “surveying, leveling or alignment laser product,” CDRH will not object to compliance with the IEC Class I emission limit set forth in IEC 60825-1:2007.

FDA indicates that this guidance supersedes in part the policy set forth in the Guidance on Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50), which will cease to be effective by its own terms upon the effective date of amendments to the regulations applicable to laser products. However, because IEC Classes 1M and 2M do not have comparable analogs in FDA’s classification system, manufacturers should not conform to the parameters for IEC Classes 1M or 2M unless they also comply with FDA’s performance standards for laser products.

To get news like this in your inbox daily, subscribe to the Sandler, Travis & Rosenberg Trade Report.

Customs & International Headlines