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Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation

 
• By Sue Darcey

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.

Alarm button

A last-minute US Department of Health and Human Services (HHS) notice set to waive regulatory review of more than 80 different types of medical devices granted emergency use authorization (EUA) by the Food and Drug Administration to address the pandemic has drawn the concern of a leading medtech product safety advocate.

The 14 January notice exempted from regulation seven types of gloves, but after a comment period and review period of 120 days, the regulators could expand that waiver to another 84 devices, including products critical to addressing the COVID-19 pandemic

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