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 (http://www.fdawatch.net/) . Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net (mailto:info@fdawatch.net) . Music by Dvir Silver (https://pixabay.com/users/sonican-389...) from Pixabay (https://pixabay.com/music/?utm_source...) .