Inside the FDA: Clearances, Recalls & Today’s Politics

I’m joined by Naomi Schwartz, former FDA diabetes reviewer and VP of regulatory strategy at Medcrypt, who shares firsthand insight into how device classifications, De Novo pathways, and FDA warning letters work. We break down why the FDA can feel like a barrier to innovation, how DIY diabetes tech and cybersecurity risks are evaluated, and the difference between wellness devices and regulated medical devices. We examine recent workforce disruptions from DOGE and political pressure—and what all of this means for the future of med tech innovation and patient safety.

 

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DISCLAIMER: This podcast is not medical advice and is for educational purposes only. Always consult with your doctor before making changes to your health care. 

 

*10-day trial eligibility may vary. Full terms and conditions apply. Visit omnipod.com/diabetech for clinical disclaimers, terms and important safety information. The Pod has an IP28 rating for up to 25 feet for 60 minutes. The Omnipod 5 Controller is not waterproof.

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