Elizabeth Schmidtlein Crockett

King & Spalding

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

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

4/21/2021  /  Department of Health and Human Services (HHS) , Exemptions , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Register , Food and Drug Administration (FDA) , Medical Devices , Pre-Market Notification , Public Health Emergency , Public Notice
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