With Sun Setting On Trump Admin, HHS Finalizes Regulatory Review Rule
In a change from the draft, the final rule exempts device-specific regulations from scheduled review.
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The lawsuit argues that the regulatory review proposal was “arbitrary and capricious” and should not be allowed to go into effect.
The tactic aims to allow the new Biden administration to scrutinize so-called “midnight rules” issued in the final days of the Trump administration before they take effect. One reg targeted by the freeze is the recent SUNSET rule from the US HHS, which would require the department and its agencies – including the FDA – to review all regulations every 10 years to determine whether they’re still necessary.
The US Medicare agency issued on 12 January its final MCIT rule allowing instant reimbursement for FDA breakthrough devices – unless the incoming Biden administration blocks it.