FDA looks to strengthen premarket review of devices

January 24, 2019


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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