Device industry scrambles as FDA job cuts cause delays

The sudden firing of over 200 FDA employees, particularly from the Center for Devices and Radiological Health (CDRH), is causing delays in medical device submissions and increasing pressure on the remaining staff. The cuts, which largely affected probationary employees and those with expertise in artificial intelligence and digital health, have been criticized by industry groups like Advamed for potentially putting patients at risk and slowing the approval process for new technologies. The firings have already disrupted scheduled meetings and could extend the timeline for bringing new products to market by months or even years.

The FDA and the Department of Health and Human Services have not disclosed the exact number of employees cut, but reports suggest that the CDRH lost a significant portion of its workforce, including key personnel involved in evaluating complex devices. The cuts are part of broader federal workforce reductions under the Trump administration, led by the Department of Government Efficiency and adviser Elon Musk. Concerns have been raised about the impact on safety and postmarket surveillance, and Advamed is assessing the legality of the firings while focusing on addressing the issue through user fees and potential legislative action.

Key takeaways:

The sudden firing of FDA employees is affecting medical device submissions, potentially delaying new products and increasing pressure on remaining staff.
Advamed and other industry figures have criticized the cuts, citing risks to medical device companies and patient safety.
The firings have particularly impacted staff with AI expertise, which could slow the approval process for complex devices.
The cuts may affect the FDA's ability to meet staffing and review goals set by user fee agreements, raising concerns about the legality and impact of the firings.

Device industry scrambles as FDA job cuts cause delays

Key takeaways:

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