.png){kind=logo}
Recent mass layoffs at the US Food and Drug Administration (FDA) under the Trump Administration are expected to affect several industries, including AI, healthcare, and food. It will slow down medical device approvals and disrupt regulatory decision-making. Experts warn that the agency may struggle to meet review timelines outlined in the Medical Device User Fee Act (MDUFA).
The layoffs primarily affected the FDA’s Center for Devices and Radiological Health (CDRH), where around 200 staff members were let go. Of these, 50% held positions partially funded by industry-paid user fees. Legal experts caution that these cuts will make remaining employees prone to take controversial regulatory actions, potentially affecting safety requirements for new medical devices.
Michael Gaba, vice chair of the FDA practice group at Polsinelli, criticized the move, stating, “There is nothing strategic about these cuts.” He added that these layoffs could lead to a more cautious regulatory environment, with officials avoiding aggressive postmarket requirements or additional clinical trials for certain devices.
One of the high-profile firings was Ross “Rusty” Segan, director of the Office of Product Evaluation and Quality (OPEQ). His removal has raised concerns about stability within the agency’s device review division, which plays a key role in evaluating the safety and effectiveness of new medical products.
The FDA staffing cuts have also affected the employees who are overseeing artificial intelligence (AI) and digital health technologies. Thus, raising alarm among regulators and healthcare professionals. This comes as hospitals and insurers increasingly integrate AI into medical decision-making.
Despite the FDA cuts, the Trump Administration has committed to a US$500 billion investment in AI infrastructure. Industry observers note the contradiction, as the government simultaneously reduces regulatory oversight while expanding AI initiatives. Elon Musk’s US DOGE Service has also proposed using AI to identify inefficiencies in government spending.
The full impact of the layoffs remains uncertain, but regulatory experts warn of potential delays in FDA decision-making and increased scrutiny from lawmakers and industry stakeholders. Some of the fired employees may challenge their terminations. The FDA will also need to find ways to maintain regulatory efficiency despite reduced staffing.
