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January 15, 2021

Health Law Weekly

HHS Seeks to Exempt Certain Low-Risk Medical Devices from Premarket Notification Requirements

  • January 15, 2021

The Department of Health and Human Service (HHS) issued a notice January 11 permanently exempting seven Class I devices—all of them types of medical gloves—from premarket notification requirements under Section 510(k) of the Food, Drug, and Cosmetic Act (FDCA).

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