How Device User Fees Work as FDA Readies MDUFA VI for Congress

FDA's device center is preparing to send its next user fee agreement to Congress, Center for Devices and Radiological Health Director Michelle Tarver said at a town hall during The MedTech Conference in Boston, as reported by RAPS on Oct. 21, 2026. "This is a real milestone, and the final agreement is now going through clearance," Tarver said, according to RAPS. The report said the agreement is targeted for submission to Congress by January 2027.

The agreement, known as MDUFA VI, would cover fiscal years 2028 through 2032. Here is how the program works.

Who pays, and for what

Under the Medical Device User Fee Amendments, device makers pay FDA when they register their establishments or submit a new device for marketing, according to FDA's MDUFA VI fact sheet. FDA's fees page says device user fees were first established in 2002 and have been renewed several times since; the current program, MDUFA V, runs through Sept. 30, 2027.

For fiscal 2027, which began Oct. 1, 2026, FDA lists these standard fees, with lower rates for qualifying small businesses:

• 510(k) premarket notification: $28,653 (small business: $7,163)
• De Novo classification request: $191,020 (small business: $47,755)
• PMA and related applications: $636,732 (small business: $159,183)
• Annual establishment registration: $13,785

In exchange, FDA commits to performance goals on how quickly it reviews submissions. Those goals are negotiated in advance and written into a commitment letter.

How a new deal is made

FDA's MDUFA VI page lists the steps so far: seven stakeholder consultation meetings and 14 FDA-industry negotiation meetings between October 2025 and March 2026, a public meeting on Aug. 5, 2026, a Federal Register request for comments, and a draft commitment letter on performance goals and procedures for fiscal 2028 through 2032. The fact sheet says the draft recommendations followed more than a year of public input, negotiations with industry and consultations with patient groups, health professionals and academic experts.

What the draft would change

According to the fact sheet, the draft keeps fee levels stable through fiscal 2032 while changing the structure so that foreign firms contribute what FDA calls "an appropriate share" of revenue. FDA says fees for all submission types, including PMA, De Novo and 510(k), are slated to decrease in fiscal 2028. Qualifying US small businesses would get a new registration fee waiver that would no longer require them to show financial hardship.

FDA says it has committed to continuing MDUFA V's performance goals, "at or above 90% in all cases." New features include a $2,000 fee for certain initial pre-submission meetings, credited back against a later marketing submission fee, and a De Novo "walkthrough" meeting within the first 30 days plus a new "not grantable" decision option. MDUFA V's annual hiring targets and penalties would be replaced with reporting on recruiting, onboarding and retention.

The fact sheet gives the scale of the program: more than 21,000 submissions in fiscal 2025, including 4,151 510(k)s, 69 De Novo requests and 581 PMA originals, panel-track, 180-day and real-time supplements, and about 30,000 registered device establishments, 54% of them foreign.

Where the center stands

RAPS reported that, as of Sept. 30, CDRH was on track to meet nearly all its MDUFA V review goals and authorized 151 novel devices in fiscal 2026. CDRH lost about 22% of its staff and about 30% of its reviewers over the past year and a half, according to the report, and hired 65 people at its White Oak campus in fiscal 2026, above the MDUFA V goal of 63. "We have been on a recruiting tear," Tarver said.