The FDA serves as a guardrail for diabetes technology, balancing innovation with patient safety while operating within strict legal and scientific limits. While regulatory timelines and scrutiny can feel frustrating, conservative risk benefit analysis is what keeps unsafe devices from reaching people who rely on this technology every day.

That challenge has grown as diabetes devices have become more complex. Insulin pumps, continuous glucose monitors (CGMs), and automated insulin delivery systems (AIDs) now function as interconnected, software driven platforms. Evaluating their safety requires a systems level approach that accounts for algorithms, wireless communication, interoperability, and real world failure scenarios.

We spoke with former FDA diabetes reviewer Naomi Schwartz, who is now VP of regulatory strategy at Medcrypt, where we get into how device classifications work, why warning letters are issued, recent politics and cuts from DOGE, and how the industry could achieve faster review process for diabetes tech. Listen to the episode above or watch in video below.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.