Lawyer: Biden Reg Freeze Puts On Ice Potential Premarket Review Waivers For 84 Device Types
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.
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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.
Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation
National Center for Health Research president Diana Zuckerman is concerned about a new joint notice from the US HHS and the FDA designed to deregulate a slew of devices and tests.
The US HHS and the FDA on 14 January published a notice that permanently waives premarket notification requirements for seven types of gloves that were given temporary waiver during the pandemic. Regulators are looking to expand the waiver to 84 other products.