Keeping Up with Medical Device Manufacturing and Digital Health

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: Survey notes nearly 73% of daily cosmetic users believe FDA tests cosmetics for safety

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.