CDRH 2025 Annual Report Shows 124 Novel Devices, Fewer Guidances and No Staff Count

The Food and Drug Administration's device center authorized 124 novel medical devices in 2025 and received more submissions than the year before, according to an annual report released on Wednesday, the first since staff cuts at the agency last year. The report does not say how many people the center now employs.

The CDRH Annual Report 2025 says the Center for Devices and Radiological Health received 21,780 regulatory submissions, oversaw 25,530 registered device manufacturing firms and issued 21 guidances during the year. The 124 novel authorizations included the first blood test to diagnose Alzheimer's disease, which the report describes as "one of the highest annual totals in the Center's more than 40-year history."

The center authorized 120 novel devices and received 20,727 submissions in 2024, MedTech Dive reported. It issued 38 guidances that year, compared with 21 in 2025, according to the outlet, which tied the drop to a broader deregulatory push by the administration.

Staffing left out

"This year brought several changes that required us to adjust our pace and focus our efforts," CDRH Director Michelle Tarver wrote in the report's opening message. "We have been thoughtful in prioritizing the work with the greatest impact on patients and public health."

Unlike earlier editions, the report does not include workforce totals, Department of Health and Human Services spokesperson Andrew Nixon told MedTech Dive by email; he did not give a figure for 2025 when asked. The center had 2,260 dedicated employees in 2024, and ProPublica reported in August that it had lost about 22% of its workforce through cuts and departures, according to MedTech Dive.

Among its goals for 2026, the report lists strengthening "CDRH resilience to adapt to staffing changes, evolving processes, and shifting technological demands," alongside implementing the new Quality Management System Regulation and expanding postmarket safety work.

Review goals and programs

CDRH said that in 2025, "despite resource challenges," it was on track to meet key review-time targets under the fifth Medical Device User Fee Amendments, covering premarket approval applications, De Novo requests, 510(k) notifications and pre-submissions. It held six industry meetings and three stakeholder consultation meetings in 2025 as negotiations began on the next agreement, MDUFA VI.

The report says 149 devices received breakthrough device designation in 2025 and 44 designated devices received marketing authorization. More than 1,300 AI-enabled devices have been authorized to date, and more than 250 devices have been authorized using real-world evidence. The center also received 51 shortage notifications, 14 of which required FDA action.

Other 2025 work highlighted in the report includes extending the Early Alert pilot, which speeds communication about potentially high-risk recalls, to all device types, and announcing the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot for digital health devices with the Centers for Medicare and Medicaid Services.

The release came as a partial government shutdown affecting other federal health agencies appeared likely. The FDA will keep operating as usual because it has already been funded for the full year, Regulatory Focus reported on Friday.