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Guidance Issuing OfficeCenter for Devices and Radiological Health
The Performance Standard for Laser Products (21 CFR 1040.10 and 1040.11) became effective August 2, 1976. Lasers and products containing lasers manufactured on or after that date must conform to the applicable provisions of the standard. In addition, manufacturers will be required to certify that their products comply with the regulations and to furnish reports to the Bureau of Radiological Health which clearly substantiate the product compliance.
This document has been prepared in order to assist manufacturers in developing and implementing quality control and testing programs which are in accordance with good manufacturing practices and which assure compliance with The standard and adequacy of safeguards against hazardous electronic product radiation. Because laser products may operate over a large variety of wavelengths, emission durations, and spatial characteristics, a detailed step-by-step protocol would be of very limited application. The purpose here, therefore, is to set forth a general description of the procedures and, philosophy of quality control as appropriate for laser products, beginning from the concept and ending after final testing of the product.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.