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FDA looks to strengthen premarket review of devices

January 24, 2019

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The Food and Drug Administration is seeking public comment on the agency’s efforts to modernize the 510(k) program, which accounts for the majority of medical devices that the FDA reviews.

A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (predicate device) that is not subject to premarket approval.

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