Final reg on reuse to be published in July
Final reg on reuse to be published in July
The Food and Drug Administration will publish the final regulation on reuse of single-use devices in July and phase in the implementation in 2001, according to Larry Kessler, ScD, director of the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health.
The agency has received a significant number of comments advising the agency to eliminate the new risk categorization scheme, and the agency is considering those comments, Kessler says. (For more information on the proposed regulation and risk categorization scheme, see Same-Day Surgery, February 2000, p. 23, and January 2000, p. 1.)
For reuse policy documents and correspondence, see the FDA Web page: www.fda.gov/ cdrh/reuse.
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