Jeremiah Kelly

Jeremiah Kelly

Venable LLP

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Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more

10/9/2023  /  Clinical Evaluations , Comment Period , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Premarket Approval Applications

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

3/28/2023  /  Clinical Laboratories , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Public Health Emergency
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