We recently received a reader inquiry from our July InCompliance column on laser labeling. The reader raised a question about the FDA/CDRH and IEC standards’ harmonization, in regards to the FDA’s ‘Laser Notice No. 50’ document. The ‘Laser Notice No. 50’ guidance document from 2007 states that CDRH will not object to conformance with many sections of IEC 60825-1, as it intends to harmonize its requirements with those of the IEC standards (a change which has not taken place as of yet, even after the standards were revised in 2014.)
We wanted to share our response in case it helps anyone else with similar questions. To help clarify the issue, we turned to Bill Janssen, a Certified Laser Safety Officer (Board of Laser Safety). He's also a member of the Laser Institute of America, the American Society for Laser Medicine and Surgery, and the ANSI Z136 Safe Use of Lasers (series) technical and standards subcommittees.
Here’s his response regarding his recommendation for U.S. laser manufacturers: “The FDA’s guidance documents (i.e. 21CFR 1040.10 [section (g) Labeling requirements], 21CFR1040.11 [medical lasers], Laser Notice No. 50 and FDA Form 3632 Guide for Preparing Product Reports for Lasers and Products Containing Lasers [section 3.3 Warning logotype]) describe the conditions which laser product manufacturers may introduce into the United States commerce laser products from Europe. For U.S. manufacturers, I would still recommend to my clients that they comply with the CDRH regulation, which means using the circa-1941 OSHA-style warnings.”