FDA Intends to Recognize Compliance With International Performance Standards for Lasers
Laser products that conform to comparable sections of International Electrotechnical Commission standards do not have to also comply with certain Food and Drug Administration regulations on laser products, FDA said in a draft guidance document issued Jan. 19. Many of…
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the FDA standards duplicate provisions of the international IEC standards, and the “IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA’s performance standards,” the agency said. FDA eventually intends to harmonize its standards with the IEC requirements, it said. In the meantime, “FDA does not intend to consider whether laser products are in compliance with certain sections of 21 CFR 1040.10 and 21 CFR 1040.11 if the manufacturer conforms to the comparable sections of the IEC Standards: IEC 60825-1 Ed. 3.0 and IEC 60601-2-22 Ed. 3.1,” as listed in the guidance document. FDA in 2007 issued similar guidance related to earlier editions of the IEC performance standard.