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FDA LACKS STATUTORY AUTHORITY TO RESCIND 510(K) NOTIFICATIONS

This article was originally published in The Gray Sheet

Executive Summary

FDA LACKS STATUTORY AUTHORITY TO RESCIND 510(K) NOTIFICATIONS after a device has been deemed substantially equivalent through the premarket notification process, the Health Industry Manufacturers Association contends in an Oct. 25 citizen's petition. "There is no evidence in the legislative history" of the 1976 device amendments or the Safe Medical Device Act of 1990 "that Congress ever contemplated the need for FDA to withdraw a 510(k) order after it was issued," HIMA says.
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