ARTICLE SUMMARY:
Officials from FDA, industry, and consumer and clinical groups discussed priorities for reauthorization of the medical device user fee program at an early-August meeting. Here are five key takeaways from the session.
FDA, industry, and other groups engaged in the medtech sphere laid out the public groundwork for upcoming talks on reauthorizing device user fees during an August 4 meeting held at the agency’s Maryland headquarters. A proposal for the next iteration of the device user fee program, MDUFA VI, will need to be hammered out in negotiations between FDA and industry groups, and ultimately approved by Congress, by September 2027. The early-August meetup served as the official kickoff of those efforts, which will be crucial to setting the context for industry-FDA interactions through 2032.
Here are Market Pathways’ five key takeaways from the meeting, with an eye toward the primary dynamics and policy issues at play for the reauthorization effort ahead.
