The U.S. Food and Drug Administration (FDA) plans an increase of 7% in medical device user fees that will go into effect October 1, 2020. This will slightly raise costs for premarket submissions including 510(k) Premarket Notifications, reports Emergo.
FDA’s new Medical Device User Fee Amendment (MDUFA) fee schedule comes into effect October 1, 2020, the start of the agency’s 2021 fiscal year. As usual, the fee schedule features both standard rates as well as significantly lower small-business rates for qualifying manufacturers.
US market applicants seeking to qualify for FDA’s 2020 user fee rates should submit premarket applications by September 30, 2020.
Read the full story on Emergo.