On May 8, 2019 FDA has finalized its guidance on the regulatory requirements applicable to laser products entitled “Final guidance – Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) ”.
FDA has set in place their own radiation safety product performance standards (21 CFR 1040.10 and 1040.11) that must be met by manufacturers in order for laser products to be legally placed on the U.S. market. Therefore, devices sold on the U.S. market as well as other countries may have to comply with international consensus standards IEC standards and FDA regulatory requirements.
Major stakeholders such as Laser Illuminated Projector Association (LIPA) and flow cytometry IVD systems manufacturer Beckman Coulter, insisted for changes in the FDA’s proposed guidance asking for full harmonization with the IEC standards, claiming that such changes would have a noteworthy impact on the certification efforts and costs.
Despite major changes brought to the document’s text after FDA received the industry’s feedback, the final guidance falls short of full harmonization with 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.
This guidance replaces the “Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs)” issued on February 18, 2015.