What's Ahead for FDA & MedTech
Show notes
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
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Music by Dvir Silver from Pixabay.