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GUIDANCE DOCUMENT

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) Guidance for Industry and Food and Drug Administration Staff May 2019

Final

Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)

Docket Number:
FDA-2017-D-7011
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance describes the Food and Drug Administration’s (FDA) approach regarding manufacturers’ compliance with FDA’s performance standards for laser products. FDA recognizes that while there are many similarities between International Electrotechnical Commission (IEC) standards 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements, Edition 3.0 and 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, Edition. 3.1 and FDA’s laser performance standards, there are clauses of these IEC standards that differ significantly from FDA’s performance standards for laser products. For the manufactures that conform to the clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 that FDA identifies as comparable with 21 CFR 1040.10 and 1040.11, FDA does not intend to enforce the applicable requirements in 21 CFR 1040.10 and 1040.11.


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All written comments should be identified with this document's docket number: FDA-2017-D-7011.