The U.S. Food and Drug Administration (FDA) is seeking public comment on how best to evaluate the performance of artificial intelligence (AI) technologies integrated within medical devices.
Published in late September by the FDA’s Digital Health Center of Excellence, the “Request for Public Comment” is intended to obtain information and ideas from industry and other interested parties related to “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world.”
The FDA says that it is seeking details on the following issues related to the use of AI in medical devices:
- Performance metrics and indicators;
- Real-world evaluation methods;
- Postmarket data sources and quality management;
- Monitoring triggers and response protocols;
- Human-AI-interaction and user experience; and
- Additional considerations and best practices.
The FDA’s Request for Public Comment is available at https://www.fda.gov/medical-devices/digital-health-center-excellence/request-public-comment-measuring-and-evaluating-artificial-intelligence-enabled-medical-device?utm_medium=email&utm_source=govdelivery.
Comments can be filed electronically through the Regulations.gov website at https://www.regulations.gov/document/FDA-2025-N-4203-0001 through December 1st.