What's Ahead for FDA & MedTech
· 50 min · S1 E59
Episode What's Ahead for FDA & MedTech
Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Rusty Segan, CEO of Medical & Scientific Advisors. You'll hear their takeaways from AdvaMed's MedTech Conference and emerging FDA issues, plus their thoughts on CDRH priorities under Dr. Michelle Tarver and the evolution of risk-based device regulation; MDUFA reauthorization and potential device policy changes; QMSR implementation and FDA compliance and enforcement expectations; FDA oversight of AI-enabled medical devices, including PCCPs, adaptive AI, and postmarket monitoring; the RAPID pathway and alignment of FDA authorization with Medicare coverage and reimbursement; and much more
In our headlines segment, Wayne highlights these major developments:
Pharma: FDA launches Rare Disease Framework Initiative to streamline drug development while allowing flexibility
Pharma: FDA finalizes guidance for software and apps used alongside prescription drugs
Devices: Medtech industry outlines top policy priorities ahead of MDUFA VI
Food: FDA finalizes guidance on new dietary ingredient notification requirements
Cosmetics: FDA flags misleading social media promotion of Evolus' Jeuveau
To 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.
Links in the notes 2
Shows are listed from Apple Podcasts' charts and directory, and Podcast Index where it is used. Every show and episode belongs to its publisher and plays from the publisher's own feed; this site hosts none of them. Explicit shows are for adult profiles only, and children’s profiles hear only children’s shows. More about this list.