Laser Products-Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50); Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Laser Products--Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Laser Notice 50)." This guidance document describes the conditions under which laser product manufacturers may introduce into U.S. commerce laser products that comply with the IEC standards 60825-1, as amended, and 60601-2-22. This guidance document also describes additional requirements of the FDA standard and alternate certification statements to be used with such products. This guidance document provides interim relief to manufacturers from conformance with two differing standards and precludes the need for submission of many requests for variances from the FDA standard while FDA harmonizes with many of the IEC requirements for laser products.