FDA Job Cuts Threaten Medical Device Approvals, Industry Braces for Delays

The recent firing of over 200 employees at the FDA’s Center for Devices and Radiological Health (CDRH) is already causing delays in medical device approvals, raising concerns across the industry. Key personnel, including AI and digital health experts, were among those let go, leaving companies uncertain about the impact on ongoing and future device submissions. Legal and industry experts warn that these cuts could extend the regulatory process by months or even years, especially for complex technologies like artificial intelligence-driven medical devices. Trade group Advamed has strongly criticized the move, emphasizing potential risks to innovation and patient care.

The layoffs, which primarily affected probationary employees, come amid broader federal job cuts and have disrupted scheduled FDA review meetings. With the CDRH previously expanding under user fee agreements to meet growing industry demands, stakeholders fear the loss of specialized staff will severely slow pre-submission consultations and clinical trial feedback. Advamed and other industry leaders are exploring options to reverse the cuts, potentially through congressional action, to prevent long-term setbacks in medical device innovation and accessibility.