FDA Invites Chat on Renewing Device Review Fees
Published Date: 6/11/2025
Notice
Summary
The FDA is gearing up to renew its Medical Device User Fee program from 2028 to 2032, which helps speed up the review of new medical devices. They’re hosting a public meeting and asking for your thoughts before the current program ends in September 2027. This means device makers and the public get a say in how fees are collected and used to keep medical innovation moving fast!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Device Fee Authority Expires 2027
If you make medical devices, the FDA's authority to collect device user fees ends on September 30, 2027. Congress must reauthorize the Medical Device User Fee Amendments for fiscal years 2028 through 2032 for the FDA to keep collecting those fees that fund device-application review.
Fees Fund Faster Device Reviews
You may get faster access to new medical devices if the Medical Device User Fee Amendments are reauthorized for fiscal years 2028 through 2032. The program lets FDA use collected fees to support the review of device applications; the current authority ends September 30, 2027.
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Key Dates
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