The sudden firing of hundreds of Food and Drug Administration employees has already caused delays in the approval process for new medical devices, with industry leaders warning that patients may be at risk.
The agency’s device center is feeling the pinch as top executives and staff members were let go over the weekend. Advamed, a leading industry lobby group, has expressed its concerns, stating that the cuts could have negative consequences for companies and put patients at risk.
The firings are particularly concerning for those who specialize in artificial intelligence (AI) and digital health technologies. The AI expert said about half of their division was cut, leaving many staff members without clear roles or responsibilities.
Industry insiders say the firings were unexpected and caught top managers off guard. They claim that managers did not receive notice of the terminations, which have left employees uncertain about what to expect.
Advamed CEO Scott Whitaker stated that new technologies can be challenging and complicated, making it difficult for agencies to keep up with changing standards. He hopes to “correct” the situation by bringing back recently-fired staff members.
The role of user fees in staffing has also been a point of contention. Industry leaders say that the firings may have disproportionately affected newer employees hired under recent staffing milestones. The FDA will review the next Medical Device User Fee Amendments (MDUFA) with device makers in 2027, which could further exacerbate the situation.
The impact on patients is already being felt as delays in the approval process and reduced feedback from clinical trials. Q-submission meetings, which provide developers an opportunity to ask for FDA feedback on planned devices, may also be delayed or canceled entirely.
As industry leaders and experts weigh the implications of these firings, one thing is clear: the medical device industry will need to adapt to these changes in order to maintain patient safety and regulatory compliance.
Source: https://www.medtechdive.com/news/fda-cdrh-cuts-device-industry-impact/740528