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Department of Health and Human Services (HHS) › Medical Devices › Pre-Market Notification

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

Harris Beach PLLC on

From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Mintz - Health Care Viewpoints

FDA Reverses 11th Hour HHS Action to Exempt Certain Devices from 510(k) Premarket Requirement

Mintz - Health Care Viewpoints on

On April 16, 2021, the Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15,...more

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