|Today, the U.S. Food and Drug Administration (FDA) issued a Federal Register Notice announcing the availability of the draft guidance entitled, "Laser Products -- Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)." The guidance describes the FDA’s proposed approach regarding compliance with FDA’s performance standards for laser products. The FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA’s regulations.|
The draft guidance will be open for public comments and suggestions for 60 days in the Federal Register under Docket Number: FDA-2017-D-7011.
Center for Devices and Radiological Health
Food and Drug Administration
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