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.
You may also be interested in...
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.
Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.
In a change from the draft, the final rule exempts device-specific regulations from scheduled review.