The Trump Administration’s campaign to cut the federal workforce arrived at the FDA last weekend – in particular its division regulating AI in healthcare. Multiple staff cuts were reported at the Center for Devices and Radiological Health, which had been in the midst of a major overhaul of AI regulation.
A February 15 article in STAT News first reported the layoffs, which as with other recent staff reductions concentrated on FDA employees with probationary status and was part of a larger initiative that has also affected the CDC and NIH.
- The FDA layoffs reportedly landed particularly hard on staff charged with regulating AI-enabled imaging devices within CDRH, including product reviewers.
The rapid growth of medical AI has had a major impact on the center, which as of its last report had given regulatory authorization to over 1k AI-enabled devices (76% of which are for radiology).
- To deal with the deluge, CDRH reportedly had been hiring many new staffers who were still on probationary status, making them targets for layoffs (permanent federal employees have civil service protections that make them harder to fire).
FDA also has been retooling its regulatory approach to AI with new initiatives that reflect the fact that AI products continue learning (and changing) after they’ve been approved, and thus require more aggressive post-market surveillance than other medical devices…
- A draft guidance on the total product life cycle of AI-enabled devices.
- A final guidance on predetermined change control plans for post-market regulation of such devices.
- The first meeting in November of its Digital Health Advisory Committee to review AI regulation, particularly of generative AI algorithms.
So what impact – if any – will the layoffs have on the rapidly growing medical AI segment?
- The FDA may simply scale back its new AI initiatives and regulate the field under more traditional avenues that have served the medical device industry well for decades.
In another scenario, the FDA’s frenzied pace of AI approvals and initiatives could slow as the agency struggles to handle a growing number of product submissions with less staff.
- This could have serious downstream effects, especially on AI startups that rely on FDA approvals to begin generating revenue or attract venture capital investment.
The Takeaway
The FDA layoffs couldn’t have come at a worse time for medical AI, which is on the cusp of wider clinical acceptance but still suffers from shaky confidence and poor understanding on the part of both providers and patients (see story below). The question is whether providers, organized radiology, or developers themselves will be able to step into the gap being left.
