When the Algorithm Is a Device: AI, the FDA, and the Question Almost Nobody Is Asking

The AI tool you bought last quarter, the one bundled into your EHR upgrade, the one your hospital piloted on your unit. Was it cleared by the FDA as a medical device? Most physicians do not know the answer. The vendor's pitch deck almost certainly did not lead with it. And the answer matters, because once an algorithm crosses into FDA medical device territory, the rules that govern what it can claim, how it has to perform, who is liable when it fails, and what evidence the manufacturer had to produce before it reached your practice change categorically. In this episode of The Clinical Realist, Dr. Sarah Matt walks listeners through three questions: when is an AI tool a medical device, what do the three FDA approval pathways actually mean about the evidence behind a product, and what does professional liability look like when the algorithm is the one making the call. What you will take away: - When a clinical AI tool crosses the line into FDA-regulated medical device territory - What 510(k), De Novo, and PMA clearance pathways actually say about the evidence behind a product - Why the word cleared is doing enormous amounts of work in this industry - What changes for physicians, procurement teams, and health system leaders when the algorithm is making the call Book a Discovery and Clarity Session: https://calendly.com/sarahmattmd Subscribe to The Sarah Matt Briefing: https://drsarahmatt.com/newsletter-signup—Resources & Links:📖 Get the Book: "The Borderless Healthcare Revolution" is available now on Amazon and major retailers.💼 Work with Dr. Matt:Looking for a keynote speaker or strategic advisor?Visit: drsarahmatt.com🔗 Connect on Social:LinkedIn: https://www.linkedin.com/in/sarahmattmd/YouTube: https://www.youtube.com/@DrSarahMatt-ClinicalRealist📧 Subscribe to The Briefing: drsarahmatt.com/newsletter-signup —Disclaimer:The views expressed on this podcast are those of Dr. Sarah Matt and her guests. They do not necessarily reflect the official policy or position of any affiliated institutions. This content is for informational and educational purposes only and does not constitute medical advice or a professional consulting relationship.