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# Laser Product Conformance Guidance
- URL: https://www.fdaweb.com/laser-product-conformance-guidance/
- Published: 2018-01-18T12:00:00.000Z
- Updated: 2026-09-14T23:15:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140530

FDA has issued a draft guidance, *Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)*, describing the agency’s proposed approach regarding compliance with its performance standards for laser products. “Because conformance to certain comparable portions of IEC (International Electrotechnical Commission) standards identified in this draft guidance adequately address those concerns intended to be addressed by the performance standards of 21 CFR 1040.10 and 1040.11,” the [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM592775.pdf?ref=fdaweb.com) says, “FDA does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with” the two cited federal regulations.

The guidance says FDA recognizes that the IEC is a global organization that prepares and publishes international standards for electrical, electronic, and related technologies, including laser products.

“This means that manufacturers distributing products in the U.S. and other countries might have to ensure conformance of their products with IEC standards, as well as comply with FDA regulatory requirements,” it says. “Complying with FDA regulations and conforming to the identified IEC standards may cause manufacturers to duplicate their efforts. FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. Moreover, FDA believes that under the circumstances described in this guidance, conformance with certain IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA’s performance standards…. FDA eventually intends to amend its standards for laser products … to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide.”