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Proceedings Paper

FDA's Laser Notice 50: a step toward global harmonization
Author(s): Suzie L. B. Kent; Jerome E. Dennis; Gary L. Zaharek; Francis J. Eng
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Paper 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.

Paper Details

Date Published: 20 June 2003
PDF: 10 pages
Proc. SPIE 4953, Laser and Noncoherent Light Ocular Effects: Epidemiology, Prevention, and Treatment III, (20 June 2003); doi: 10.1117/12.476639
Show Author Affiliations
Suzie L. B. Kent, U.S. Food and Drug Administration (United States)
Jerome E. Dennis, U.S. Food and Drug Administration (United States)
Gary L. Zaharek, U.S. Food and Drug Administration (United States)
Francis J. Eng, U.S. Food and Drug Administration (United States)


Published in SPIE Proceedings Vol. 4953:
Laser and Noncoherent Light Ocular Effects: Epidemiology, Prevention, and Treatment III
Bruce E. Stuck; Michael Belkin, Editor(s)

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