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On December 31, 2024, the U.S. Food and Drug Administration (FDA) withdrew Laser Notice No. 50, "Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22.” Manufacturers should have transitioned to Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).
Laser Notice No. 56 describes:
- The FDA’s current approach to manufacturers’ compliance with the FDA’s performance standards for laser products, and
- How laser manufacturers can use portions of IEC 60825-1 Edition 3.0 and IEC 60601-2-22 Edition 3.1 with the FDA’s performance standard when certifying laser products.
For additional information, please see Getting a Radiation Emitting Product to Market: Frequently Asked Questions | FDA.
Questions?
If you have questions about Laser Notice No. 56, contact the Division of Industry and Consumer Education.
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