The U.S. Food and Drug Administration (FDA) has released a draft guidance on compliance with the agency’s performance standards for laser products.
Under FDA regulations, all lasers and other radiation-emitting electronic products must meet radiation safety product performance standards in order to be legally sold in the U.S. Technically, laser products must comply and be certified in accordance with provisions contained in specific sections of the U.S. Code of Federal Regulations (CFR). While the CFR requirements mostly overlap with those found in applicable international standards, manufacturers who sell laser products internationally must demonstrate compliance with both IEC standards and the FDA’s regulations, creating a duplication of effort.
Published in mid-January, the draft guidance acknowledges that the comparable portions of the relevant IEC standards, specifically IEC 60825-1 and IEC 60601-2-22, “adequately address those concerns intended to be addressed by the performance standards” set out in the relevant sections of the CFR. Therefore, the FDA “does not intend to consider whether firms that comply with the comparable IEC standards discussed in this guidance document also comply with 21 CFR 1040.10 and 1040.00.”
The FDA notes that it “eventually intends” to amend its own performance standards for laser products in order to harmonize those requirements with those found in the IEC standards.
Comments on the draft guidance can be submitted through mid-March at www.regulations.gov, citing docket number FDA-2017-D-7011.