FDA issues Two Final Guidances on Laser Products

Today, the U.S. Food and Drug Administration (FDA) issued two final guidances that better align current FDA regulatory requirements for laser product safety with international consensus standards.  This potentially reduces the regulatory burden for manufacturers and importers of laser products while assuring public health and safety. One final guidance, Laser Products -- Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Final Guidance describes the FDA’s approach  to compliance with the FDA’s performance standards for laser products. The FDA believes that under the circumstances described in this final guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of public health and safety for laser products similar to performance standards in the FDA’s regulations.

Read Laser Notice No. 56