What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation

In this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions

Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions

Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling

Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products

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

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Music by Dvir Silver from Pixabay.