Devices

Staff Up for Breakthrough Device Recall Oversight: Post

David McFarland

— 1 min read
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The FDA breakthrough medical device program is growing, and the agency should consider additional staff and resources to keep up with oversight of medical device recalls as recommended in a 2025 Government Accountability Office report. That’s the recommendation of Stanford Law School Center for Law and the Biosciences fellow Walter Johnson, writing in an online blog post.

The post cites an article Johnson wrote for the Columbia Science and Technology Law Review in which he argued that the kind of expedited regulatory review that happens in the breakthrough devices program should not be combined with immunity from tort liability. He highlights these three points:

  • the number of breakthrough designated devices that go on to receive FDA authorization is increasing over time;
  • a notable amount of the authorized breakthrough devices is cleared through the 510(k) pathway, which typically does not require clinical trials proving safety and effectiveness; and
  • recalls for breakthrough devices have already begun for this relatively new program, affecting about one in 10 of those authorized so far.

Johnson says that when those three points are considered in light of the GAO report calling for additional FDA staff and resources and perhaps also expanded legal authority, his data suggest that the agency may need even greater staffing and resources to monitor breakthrough device recalls, possibly over and above the increase recommended by the GAO.

“These innovative devices may undergo less strict regulatory review as a part of their participation in the breakthrough devices program, which may then require a higher level of regulatory surveillance and recall oversight after patients begin using these devices to ensure that public health can be adequately protected,” he writes. “While the current political moment may not facilitate providing FDA with adequate resources for regulatory supervision, policymakers should seriously consider how to implement the GAO’s recommendations as early as possible, and may need to account for breakthrough devices when they do.”

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