In this week’s roundup: An exclusive on industry’s user fee proposal; FDA withdraws recognition for a third-party 510(k) reviewer; a foreign-facility warning letter; Blackberry cyber warning; mesh and CPAP postmarket surveillance updates; AI and IVDR news in the EU; Medicare updates; and much more in global medtech regulation and policy news.
A scoop on user fee talks and a first for FDA’s third-party review program:
Industry proposes moderate user fee uptick. FDA’s five-year user fee collections under the FY 2023-2027 MDUFA V program should increase by about 13% from the current program to $1.117 billion, according to a medical device industry proposal obtained by Market Pathways. The funds would secure 11 additional full-time equivalents (FTEs) and provide general funding to the agency’s device premarket review. Also under the plan, which industry presented to FDA as part of ongoing negotiations, $127.04 million in unspent carryover balance from the current MDUFA IV program would be used to secure an additional 50 reviewers and six review supervisors and to support other programs. The proposed fee increase pales in comparison to the 66% hike in industry fees that FDA extracted during MDUFA IV negotiations four years ago. The more modest request very much aligns with industry’s push for a “back to basics” user fee agreement with no major new programs or investments. (For more details, including industry’s small opening to pilot the device center’s TPLC Advisory Program, see: “Industry Willing to Pilot FDA’s TAP Program With Existing Funds.”)