Tarver: CDRH on track to meet MDUFA metrics despite personnel losses

SAN DIEGO — Despite staff losses across the US Food and Drug Administration (FDA) earlier this year due to reductions in force (RIF), early retirements, and voluntary resignations, the agency’s top medical device regulator said her center is on track to meet its user fee performance goals.

Speaking at The Medtech Conference, Center for Devices and Radiological Health (CDRH) Director Michelle Tarver said that the challenges the agency has faced this year have also led it to think about how to do things differently. Tarver assured attendees that business continues as usual at her center despite reduced resources.

“2025 has been an eventful year filled with many transitions and changes,” said Tarver. “We've experienced changes in government policies, personnel changes, organizational [and] structural changes, and technology changes, all of which have challenged us to think and operate differently.”

One of the biggest draws for attendees at the Medtech Conference is the opportunity to engage with and ask FDA officials face-to-face questions. However, due to the government shutdown, Tarver and her FDA colleagues attended the town hall virtually via webcast.

While acknowledging the challenges that FDA staff have faced over the past eight months, Tarver stated that it has also led to rethinking how the device center operates.

“You know, change can be difficult,” said Tarver. “We all get comfortable with doing things the way we've always done it.

“However, transitions force growth, and allows for critical reflection,” she added. “Change often becomes the cradle for new focus, new opportunities, and new priorities.”

AdvaMed CEO Scott Whitaker voiced similar sentiments during a press conference the previous day, stating that they have not seen a significant adverse effect of the recent layoffs on FDA’s Medical Device User Fee Amendments (MDUFA V) obligations. He said that, unlike other product centers, it’s been encouraging for the group that Tarver has stayed in her position.

“That’s unique right now at FDA at the center director level,” Whitaker told Focus. “To us, that was a good sign of stability. I’m not suggesting there haven’t been reductions and morale issues and other things, but we haven’t seen to date performance issues that are concerning to us.”

“We hear the stories and the anecdotes [about morale], [and] we worry about the long-term impact of that story, if that’s true, but as it relates to specifics, performance metrics in MDUFA V, we haven’t seen them fall behind yet,” he added.

Whitaker added a caveat that AdvaMed does not have the most up-to-date information on the full portfolio of pending applications to make a complete assessment.

“It’s not like we like what has happened to be honest, but it’s the reality of what has happened, and we’re glad to know, at least for now, that things seem to be pretty stable, at least on the review side,” said Whitaker. “The policy side is a different question.”

During the town hall, Tarver also emphasized that the changes have not had a negative effect on CDRH’s work to meet its obligations under MDUFA V. She noted that as of 1 September 2025, the center has either met or is on track to meet key submission review goals and presented the following table.

Submission Type	Action	Review-Time Goal	FY23 Current Performance	FY24 Current Performance	FY25 Current Performance
Original PMAs, PDPs, Panel-Track PMA Supplements, and Premarket Reports	Substantive Interaction	95% in 90 calendar days	Complete	Complete	On-track
	Decision with No Advisory Committee Input	90% in 180 FDA Days	Complete	On-track	On-track
180-Day PMA Supplements	Substantive Interaction	95% in 90 calendar days	Complete	Complete	On-track
180-Day PMA Supplements	Decision	95% in 180 FDA days	Complete	On-track	On-track
Real-Time PMA Supplements	Decision	95% in 90 FDA days	Complete	Complete	On-track
De Novo Classification	Decision	70-90% in 150 FDA days	Complete	Complete	On-track
510 (k) Premarket Notifications	Substantive Interaction	95% in 60 calendar days	Complete	On-track	On-track
510 (k) Premarket Notifications	Decision	95% in 90 FDA days	Complete	Complete	On-track
Pre-Submissions	Provide Written Feedback	75-90% in 70 calendar days (or 5 days prior to meeting)	Complete	Complete	On-track

“Our performance continues to be positive despite growing demands on our organization,” said Tarver. “It is a true testament to the fortitude of our staff, and it has not been easy to accomplish these goals with fewer hands to help.”

Tarver also listed several accomplishments under MDUFA V, including converting the Accreditation Scheme for Conformity Assessment (ASCA) pilot into a full program, issuing guidance documents on pre-submissions and deficiency letters, training review staff, and making IT enhancements to improve the application submission quality. She also noted that CDRH has completed the independent assessment of MDUFA workforce metrics and is on track to complete the independent assessment of review process management by 31 March 2026.

Tarver noted that FDA authorized 120 novel devices in 2024, the third-highest number of such authorizations since 2009. She also previewed findings from FDA’s Total Product Lifecycle Advisory Program (TAP) pilot, which currently has 93 devices enrolled. She said that while the assessment is scheduled to be published at the end of January 2026, 98% have voiced that they are satisfied with their participation.

Tarver: CDRH on track to meet MDUFA metrics despite personnel losses

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