Biden Regulatory Freeze Could Slam Brakes On SUNSET Reg Review Rule From HHS
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.
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The non-partisan policy think tank wants the administration to permanently rescind a number of recent Trump HHS policies, including one that stops the FDA from regulating laboratory developed tests.
The Medicare rule, which was delayed by 60 days under a broader regulatory freeze, is seen as critical to the reimbursement of innovative devices.
King & Spalding partner Kyle Sampson tells Medtech Insight that a joint US HHS/FDA notice that could exempt a plethora of medical devices from premarket review falls under a recent regulatory freeze from the Biden administration.