By GARR Staff
August 4, 2025
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is at a critical juncture. Recent federal workforce Reductions in Force (RIFs) have significantly weakened its ability to review medical devices and diagnostics in a timely and effective manner. This not only threatens the agency’s core public health mission but also slows access to life-saving technologies and endangers U.S. leadership in the global MedTech ecosystem.
🔍 The Workforce Crisis at CDRH
The Department of Health and Human Services (HHS) issued a Reduction in Force (RIF) order in February 2025, which included a cut of about 220 device staff from the Center for Devices and Radiological Health (CDRH) (Associated Press, 2025). This was followed by additional cuts at the FDA in April 2025 that cut an estimated quarter of its staff. (Minnesota Star Tribune, 2025). Even though some were rehired, following pressure from industry leaders and the U.S. medical device trade association, they lost a number of experienced personnel in the process, according to AdvaMed’s CEO Scott Whitaker (Kelly, 2025). Whitaker went on to indicate that these job cuts into a division, already experiencing historical delays, would have a negative impact on patient care and even threaten the US position as the Medtech leader. (Kelly, 2025).
📊 Why This Matters: Public Health at Risk
The medical device industry in the U.S., regulated by FDA’S CDRH, contributes over $200-$250 billion annually to the economy and plays a crucial role in healthcare innovation (AdvaMed, 2023). CDRH oversees more than 190,000 regulated devices used in hospitals, homes, and emergency settings every day. From defibrillators and ventilators to surgical robotics and digital diagnostics, delayed access or insufficient oversight can cost lives. The RIFs have not only created a shortfall in manpower but also reduced institutional knowledge—creating vulnerabilities in complex or high-risk product evaluations, including AI/ML-based tools and software as a medical device (SaMD).
💡 What Can Be Done? Five Policy Solutions
Here are five policy strategies now under consideration by experts and stakeholders, each evaluated on its efficiency, cost-effectiveness, feasibility, and stakeholder support:
- Increase Direct Federal Appropriations: Direct funding would help restore workforce numbers and invest in hiring and training. While politically sensitive, this approach offers the fastest path to rebuilding institutional strength. Efficiency: High | Cost-Effectiveness: Moderate | Feasibility: Medium | Stakeholder Support: High (FDA, patients)
2. Expand Use of User Fees through MDUFA: Adjusting or reauthorizing user fees can inject immediate funding, though overreliance on industry contributions raises concerns about impartiality and sustainability. Efficiency: Medium | Cost-Effectiveness: Moderate | Feasibility: High | Stakeholder Support: Mixed (FDA, industry)
- Outsource Non-Core Review Functions: Low-risk product reviews could be delegated to accredited third parties, freeing internal experts for complex cases. This already occurs on a limited basis but could be expanded with new oversight mechanisms. Efficiency: Medium | Cost-Effectiveness: High | Feasibility: High | Stakeholder Support: Moderate 4. Modernize with AI and Automation: Investments in artificial intelligence and automation can help triage submissions and streamline data processing. FDA has already begun with ELSA but additional tools may help optimize reviewer time. Efficiency: High | Cost-Effectiveness: High | Feasibility: Medium | Stakeholder Support: Growing
- Leverage Global Regulatory Reliance: CDRH could formalize reliance on trusted foreign regulatory decisions (e.g., Health Canada, TGA) for certain product classes. This would avoid duplication, especially for well-characterized technologies. Efficiency: High | Cost-Effectiveness: Very High | Feasibility: Medium | Stakeholder Support: Mixed (industry supportive, some Congressional skepticism)
✅ A Balanced Path Forward
A hybrid approach—combining increased federal appropriations with targeted modernization efforts in AI and international collaboration—offers the most promising solution. It addresses both the short-term operational crisis and long-term structural challenges.
📣 Final Thoughts
The CDRH workforce is the backbone of medical device oversight in the U.S. Protecting and strengthening this capacity is not a bureaucratic issue—it is a public health emergency in disguise. Policymakers must act now to ensure that regulatory excellence keeps pace with technological innovation.
📚 References
- AdvaMed. (2023). U.S. medical technology industry facts. Advanced Medical Technology Association. https://www.advamed.org/industry-statistics/
- Associated Press (2025). FDA moves to rehire medical device, food safety and other staffers fired days earlier. The Associated Press. https://apnews.com/article/fda-layoffs-trump-doge-rehired-medical-devices-85d4743e4ce88dbe3b99c813bad4b702
- Kelly, S. (2025, February 19). Advamed CEO warns FDA job cuts put patients, industry at risk. MedTech Dive. https://www.medtechdive.com/news/Advamed-Whitaker-HHS-letter-FDA-layoffs/740399/
- The Minnesota Star Tribune. (2025) As FDA slashes workforce, number of new medical devices reaching the public has fallen. https://www.startribune.com/fda-layoffs/601322062