FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more

The US Food and Drug Administration (FDA) would receive new authorities under proposals in legislation introduced alongside the Medical Device User Fee Amendments (MDFUA V) reauthorization bill and in its FY2023 budget request. Those authorities include requiring medical device manufacturers to address cybersecurity, fixing a loophole with generic drug patent challenge exclusivity and clarification of the term medical device remanufacturing.