The U.S. Food and Drug Administration (FDA) has issued a guidance to clarify the standards by which it evaluates certain performance aspects of laser equipment used in surgical, cosmetic, therapeutic and diagnostic applications.
Published in early May, the guidance “Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1,” clarifies the FDA’s intended interpretation of differences in specific performance requirements between these standards and its own regulations. Specifically, the guidance makes clear that the FDA does not intend to enforce specific performance requirements as stipulated in CFR 1040.10 and 1040.11 that conflict with comparable performance requirements detailed in the latest versions of the IEC standards.
In the guidance, the FDA acknowledges the advantages of “universal set of device-specific criteria and requirements” and notes that, without the clarification offered in the guidance, manufacturers distributing laser medical devices in the U.S. might be required to demonstrate conformity with the performance requirements of both the IEC standards and the FDA’s regulations. The FDA also notes its intention to eventually harmonize its own performance requirements for laser products with those detailed in the IEC standards.