Medical Device Regulation

FDA Rehires Medical Device Staffers After Mass Firings: Costly Chaos Ensues

Following mass firings at the FDA, numerous probationary staffers, primarily in medical device and food safety review, were unexpectedly reinstated. This reversal, impacting entire teams, followed industry lobbying efforts and resulted from the chaotic cost-cutting measures implemented by the administration. The reinstatements primarily affected those whose roles were partially funded by industry fees, unlike employees in other divisions, such as the tobacco center, which received no such reversal. The FDA has not yet released official figures on the number of employees fired or reinstated, but the situation highlights the significant disruption caused by the initial terminations and their subsequent reversal.

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Musk’s Brain Implant Firm: FDA Reviewers Fired Amidst Controversy

Over the weekend, approximately 20 FDA employees in the office of neurological and physical medicine devices were terminated, impacting the agency’s review of medical device applications, including those from Neuralink. While the firings weren’t explicitly targeted at Neuralink reviewers, the loss of these employees, many of whom worked on Neuralink’s applications, will hinder the agency’s efficiency and potentially compromise safety. These probationary employees were dismissed despite positive performance reviews, raising concerns about the process and potential implications for Neuralink’s clinical trials. Outside experts express worry about the impact on the safety of trial participants.

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