The Food and Drug Administration’s medical device center issued its first annual report since sweeping staff cuts enacted by the Trump administration last year. The Center for Devices and Radiological Health continued to review and authorize as many submissions as in previous years, although the center issued fewer policy documents.
“This year brought several changes that required us to adjust our pace and focus our efforts,” CDRH Director Michelle Tarver said in the report. “We have been thoughtful in prioritizing the work with the greatest impact on patients and public health.”
The CDRH authorized 124 novel medical devices in 2025, compared with 120 last year, according to the report. The center also received more submissions — a total of 21,780, compared with 20,727 last year.
By the numbers: CDRH 2025 report
124
Number of devices authorized
149
Devices that received a breakthrough designation
44
Breakthrough devices authorized
21,780
Device submissions
One key data point missing from the report was the number of staff at the center. Unlike previous years, this report does not include workforce totals, Department of Health and Human Services spokesperson Andrew Nixon said in an email. Nixon did not share a total for 2025 when asked.
In 2024, the CDRH had a total of 2,260 dedicated employees. ProPublica reported in August that the center had lost about 22% of its workforce, including cuts and departures.
Staffing numbers are important to ensure the CDRH has enough workers to review devices and handle recalls, among other tasks. A five-year user fee agreement between the CDRH and the medical device industry, which set how much funding the center can raise from the industry in exchange for meeting certain goals, also included a hiring stipulation.
In 2024, the CDRH said it hired 42 people to meet its hiring targets for the agreement, called the Medical Device User Fee Amendments, or MDUFA V. The CDRH shared updates on its other progress toward MDUFA V, saying the center is on track to meet key targets for review timelines “despite resource challenges.” Negotiations are currently underway for the next five-year agreement.
Policy updates
The FDA’s device center issued fewer guidances than last year, amid a broader deregulatory push by the Trump administration. The CDRH issued a total of 21 guidances, compared with 38 in 2024.
One notable update was a final guidance published last year on cybersecurity considerations for premarket submissions. The FDA also issued drafts on pulse oximeter testing and labeling recommendations, and on the contents of marketing submissions for devices with artificial intelligence-enabled software.
The center also added and expanded pilot programs. It expanded early alert communications about potential high risk recalls to all device types. The CDRH also launched a new pilot program for digital health devices, called Technology-Enabled Meaningful Patient Outcomes, or TEMPO, where companies can request that the FDA waive certain premarket requirements while they collect real-world data through a related program in the Centers for Medicare and Medicaid Services.
Stakeholders are watching for future action on AI as the number of AI-enabled devices regulated by the FDA grows. Last year, the center convened a digital health advisory committee to discuss digital mental health devices, including the use of therapy chatbots, but no regulation has yet been proposed.
