Nancy Stade

Nancy Stade

Foley Hoag LLP

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

4/5/2023  /  Artificial Intelligence , Food and Drug Administration (FDA) , Machine Learning , Manufacturers , Medical Devices , Medical Software , New Guidance , Policies and Procedures , Technology

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

3/31/2023  /  Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency , Public Health Service Act
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