- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health
This guide briefly summarizes the requirements of the regulations under the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control, that applies to manufacturers of laser products. It explains the performance, labeling, and informational requirements of the standard and the procedures for remedial actions and for variances or exemptions. It does not replace the regulations, however, and if there is any conflict between the guide and the regulations, the regulations must prevail. Throughout this guide, pertinent sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses. Please consult them before making design or procedural decisions. The guide is current through the most recent amendments to the standard which were published in 1985.
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.