Richard Starr

Venable LLP

+ Follow Contact

Latest Posts › Medical Devices

Share:

AI On the Prize: Decoding FDA's Latest Guidance

Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more

1/16/2025 / Artificial Intelligence , Bias , Biologics , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Premarket Approval Applications , Product Development Protocols , Regulatory Requirements , Risk Management , Software , Transparency

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Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more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

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

4/24/2023 / Department of Defense (DOD) , Emergency Use Authorization (EUA) , Expedited FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Military End Use , Pharmaceutical Industry

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

4 Results

View per page

Page: of 1