Overview
- Commissioner Marty Makary said devices and software that provide general health information can operate without FDA regulation if they do not claim medical- or diagnostic-grade performance.
- Products marketed as providing clinical measurements, such as blood pressure readings suitable for diagnosis or treatment decisions, will remain under FDA oversight.
- The FDA issued guidance on AI support tools and indicated it does not plan to regulate platforms that merely provide information, including services like Google and ChatGPT.
- Makary emphasized that clinicians and the marketplace should determine the accuracy and adoption of nonmedical-grade wearables, with the FDA focusing on guarding against major safety risks.
- The commissioner cautioned against changing medications based on screening estimates, and Reuters reported shares of Abbott, Medtronic, Dexcom, and Garmin rose following the clarification.