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Lawyer: Biden Reg Freeze Puts On Ice Potential Premarket Review Waivers For 84 Device Types

 
• By Shawn M. Schmitt

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.

Ice cubes square with drops water clean on blue background.

A recent notice from the US Department of Health and Human Services and the Food and Drug Administration that could lead to the exemption of 84 types of medical devices from premarket review falls under the umbrella of a Biden administration regulatory freeze, an attorney told Medtech Insight.

In their joint 14 January notice, the HHS and the FDA suspended premarket notification requirements for seven low-risk class I devices – all of them gloves. The regulators said...

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