In a searing rebuke, the Biden administration is formally withdrawing a last-minute proposal by the Trump administration to exempt a wide swath of medical devices and artificial intelligence tools from regulatory review.
Officials with Biden’s Health and Human Services Department and the federal Food and Drug Administration posted a document on the federal register indicating that they will not proceed with the proposed exemptions. The document sharply criticizes a lack of transparency by Trump officials and cites errors and badly flawed logic in proposing to relax scrutiny of some devices whose malfunctioning could result in serious harm or even death.
“We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the Notice,” the document states. “Some of these proposed exemptions include device types that are indicated for a use in supporting or sustaining human life.”
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