Steven Niedelman

Steven Niedelman

King & Spalding

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FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies

During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more

12/31/2021  /  CDRH , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Draft Guidance , Emergency Use Authorization (EUA) , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

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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