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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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