9 Jan 2015
FDA Issues Guidance on Children's Toy Laser Products
The Food and Drug Administration recently finalised 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 labelling of these items.
The 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 1 August 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, the 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 on-going, CDRH recommends that manufacturers keep children's toy laser products within the FDA Class I or IEC Class 1 emission limits in order to minimise 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.
The guidance covers any toy manufactured, designed, intended or promoted for use by children under 14 years of age that constitutes, incorporates, or is intended to incorporate a laser or laser system. Examples include lasers mounted on toy guns that can be used for "aiming," spinning tops that project laser beams while they spin, handheld lasers used during play as "light sabres," dancing laser beams projected from a stationary column with bright colours or pictures on the box that might appeal to children, and lasers intended for entertainment that create optical effects in an open room with bright colours or picture on the box that might appeal to children.
While U.S. law does not currently require children's toy laser products to include a Class 1 label, the FDA encourages products within the IEC Class 1 limit to bear such a designation. The agency is of the opinion that the presence of this designation on the labelling would clearly advise purchasers that the product sufficiently "minimises risk" and has been certified as such by the manufacturer. Such designation would also indicate that the product is not in a higher emission level laser class and that the safety controls and warnings required for higher class lasers are unnecessary for the product.
The FDA clarifies that the whole toy needs to be certified as a laser product unless the part or parts of the toy that can emit laser light are removable and can emit laser light independently when separated from the other parts of the toy, in which case only those laser-emitting part or parts would need to be certified. For example, a laser gunsight that is detachable from a toy gun is itself subject to applicable laser safety regulations and must be certified because it is a removable laser system.