The 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 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.
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.
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.
This guidance replaces the Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) dated February 18, 2015.
