6. The regulatory landscape is shifting
Change is afoot at U.S. FDA under the agency’s commissioner Dr. Scott Gottlieb, a pick by President Donald Trump confirmed by the Senate earlier this year.
Just this month, Gottlieb announced plans to add a new voluntary alternative pathway for medical devices which would allow clearance upon demonstration equivalence by meeting objective safety and performance criteria. The idea is to offer more regulatory flexibility for medical device companies – promoting innovation while still ensuring safety and efficacy.
FDA also recently offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions. FDA has also picked companies for its digital health pre-cert pilot – a first-of-its-kind program meant to revolutionize digital health regulation in the U.S.
On the flip side, user fees for medical device registrants increased this year.