17 February, 2025

Under the new US administration, there are rigorous changes, and we are already seeing direct impacts to all FDA branches, but disproportionately FDA device’s review branch, Center for Devices and Radiological Health (CDRH). In order to plan how to best adapt to these changes, we’d first like to present the changes that have directly affected the CDRH branch so far and speculate what affects this might have on the industry as a whole. We will continue to update this list as new information needs to be added as it is important to stay ahead of the changes to best make plans going forward.

1.All federal employees are required to come into the office 

CDRH remote-work policies that have been in place over the last 20 years to attract certain required expertise are suspended. As the FDA never had enough office space to begin with to house all the employees at their White Oak campus in Silver Spring, Maryland, there could be an issue in housing all of them; however, this issue could be mitigated by likely a high attrition rate of highly skilled FDA Medical Reviewers who are unable or uninterested in physically moving to White Oak. On the flip side, it’s possible that FDA may be more accepting to in person meetings going forward.

2. Layoff of several thousand CDRH Probationary workers

Probationary workers are any workers that have come into a new position within the last year. A probationary worker does not necessarily mean a new hire but also includes any worker who has received a promotion or switched positions at the FDA within the last year. As these many of these probationary workers were hired to fulfill Medical Device User Fee Amendments (MDUFA) commitments, this could mean longer review times in the short term if MDUFA commitments aren’t addressed soon. MDUFA is the user fees that are paid by individual companies to the government to 1) hire enough FDA headcount and expertise to be able to review each of the submissions 2) review each application in a set period of time and has been deemed mutually beneficial by both industry and FDA. Therefore, as much of this is paid through MDUFA fees, it is unclear how these layoffs will decrease governmental spending.

3. Termination of AI/ML Reviewers at CDRH 

AI/ML experts at CDRH have been disproportionately affected in the layoffs at FDA which is concerning as more and more medical device companies are continuing to find ways to integrate AI algorithms into their traditionally hardware/software medical devices coupled with new AI SaMD applications, there may be a shortage of AI/ML reviewer expertise as these applications come through.

4. Significant Cuts in NIH Funding from 65% to 15% 

NIH funds a significant amount of early research at the university level which eventually lead promising life science startups which then spin out and receive outside Angel or Venture Capital (VC) funding to grow into a mature company. Researchers and startups who are currently receiving NIH funding in a state that has not blocked this executive order (only 22 out of the 50 states have blocked it) are immediately impacted and if they are not able to find other immediate investor replacement funds.

5. Cease of all Foreign Aid 

Companies who were manufacturing low cost, high impact medical devices and interventions for developing nations have immediately ceased to receive funding and will likely not be able to weather the loss.

For all the highly skilled CDRH reviewers who have been laid off, we sympathize for your early termination. Please reach out to us as we and others we know are always looking for great new talent to join our teams and can also connect you with resources in these difficult times.

It’s hard to speculate and we will continue to update this list as we know more..