US device user fees take a hike, drug fees relatively stable
· mari serebrov
AI Briefing
- • US FDA user fees for medical device sponsors will increase by 10% on Oct 1.
- • Device establishment registration fee will rise by 21% on Oct 1.
- • Fees are part of the MDUFA agreement.
Context
Medical device sponsors will face higher US FDA user fees starting October 1. The fees, known as MDUFA fees, are increasing by 10% across the board.
The annual device establishment registration fee will see a larger increase of 21%.
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