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.

The other final guidance, Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Final Guidance clarifies the FDA’s performance standard requirements and the International Electrotechnical Commission lamp standard for Laser Illuminated Projectors.  The final guidance outlines: how to determine if laser projectors are Laser Illuminated Projectors, how to classify Laser Illuminated Projectors into risk groups, how to meet appropriate safety requirements. This guidance replaces the Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) dated February 18, 2015. Read Laser Notice No. 57