Episode Details
Back to EpisodesKeeping Up with Medical Device Manufacturing and Digital Health
Description
Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on what's happening these days at CDRH; key issues for medical device manufacturers, such as QSMR implementation and enhanced cybersecurity requirements; the evolution of digital health and its impact on clinical decision support technologies and wellness products; what could be next for user fee authorization; potential risks with AI in medical devices; and much more.
In our headlines segment, Wayne highlights these major developments:
Pharma: Advisory panel votes to recommend allowing compounding pharmacies to prepare six peptides
Devices: FDA selects Dexcom as first participant in TEMPO pilot
Food: FDA issues final order revoking the authorization for two food dyes
Cosmetics:
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