FDA's Laser Notice 50: a step toward global harmonization

Suzie L. B. Kent; Jerome E. Dennis; Gary L. Zaharek; Francis J. Eng

doi:10.1117/12.476639

20 June 2003 FDA's Laser Notice 50: a step toward global harmonization

Suzie L. B. Kent, Jerome E. Dennis, Gary L. Zaharek, Francis J. Eng

Proceedings Volume 4953, Laser and Noncoherent Light Ocular Effects: Epidemiology, Prevention, and Treatment III; (2003) https://doi.org/10.1117/12.476639
Event: Biomedical Optics, 2003, San Jose, CA, United States

Abstract

The US Food and Drug Administration, Center of Devices and Radiological Health issued Laser Notice 50 in July 2001. This Notice is a preliminary step that FDA has taken to harmonize US regulations for laser products (21 Code of Federal Regulations) with the IEC (International Electrotechnical Commission) standards for Safety of Laser Products. The paper discusses rationale for the changes and describes some of the implementation issues, including comparisons between the current standards. The impact on the regulated industry and the user community is that the same laser hazard classification scheme is used and that engineered safety features are consistentin the world markets.

Citation Download Citation

Suzie L. B. Kent, Jerome E. Dennis, Gary L. Zaharek, and Francis J. Eng "FDA's Laser Notice 50: a step toward global harmonization", Proc. SPIE 4953, Laser and Noncoherent Light Ocular Effects: Epidemiology, Prevention, and Treatment III, (20 June 2003); https://doi.org/10.1117/12.476639

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