Issue Date: June 1, 1992
Issued by: Center for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health
Topic(s): Radiological Health
Status: Final
Compliance Guide for Laser Products (FDA 86-8260)
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.
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