FDA to Discuss Next Round of Device User Fees
Published Date: 7/8/2026
Notice
Summary
The FDA is planning a public meeting on August 5, 2026, to talk about renewing fees that medical device makers pay to help speed up device reviews from 2028 to 2032. This affects companies making medical devices and could impact how much they pay and how fast their products get approved. The current fee program ends in September 2027, so the FDA wants your thoughts before finalizing new rules and fees.
Analyzed Economic Effects
6 provisions identified: 4 benefits, 1 costs, 1 mixed.
New Pre-Submission Fee With Credit
FDA proposes a new fee for initial Pre-Submissions, with sponsors later receiving a corresponding credit on certain related subsequent marketing submission fees. Under the proposal, FDA will aim to provide written feedback on at least 90% of Pre-Submissions within 70 days (or 5 days before a scheduled meeting) for up to 5,000 Pre-Submissions per fiscal year, and introduce a faster Focused Follow-Up Pre-Submission with written responses within 45 calendar days.
Firm Timelines: PMA and 510(k) Goals
FDA proposes shared outcome goals for average Total Time to Decision: 285 calendar days for original PMA and panel-track supplement submissions throughout FYs 2028 through 2032, and a 510(k) shared outcome goal that ramps from 128 calendar days in FY 2028 to 112 calendar days by FY 2032. These goals are intended to continue reducing review times and speed patient access to devices.
De Novo Decision Timing and Meetings
FDA proposes to maintain a De Novo decision goal of 90% within 150 FDA days, introduce a structured Introduction Meeting within the first 30 FDA days of review, and allow issuance of a 'Not Grantable' letter with a final determination to decline or grant within 75 to no more than 90 calendar days after receipt of the response.
User Fees Continue; RWE Funds Restricted
MDUFA VI would continue FDA's authority to collect device user fees for FYs 2028 through 2032 to support the review process. The draft commitment letter specifies that user fee revenue will be devoted solely to premarket Real-World Evidence (RWE) activities.
TAP Program Expansion and CMS Collaboration
FDA proposes to transition the TAP pilot to a sustainable, full Total Product Life Cycle (TAP) program covering all product areas with voluntary enrollment targeted to eligible devices across all Offices of Health Technology no later than October 1, 2027. TAP will focus on enhancing the Breakthrough Device review experience and includes focused engagement between FDA and CMS for technologies where a new coverage determination would be beneficial.
International Harmonization Pilot
MDUFA VI proposes a pilot where the same device with the same intended use is submitted simultaneously to FDA and at least two other medical device regulatory authorities to support coordinated premarket review; results will be evaluated and published by September 30, 2030.
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