The U.S. Food and Drug Administration (FDA) has issued a Request for Public Comment to gather feedback on practical approaches for measuring and evaluating the performance of AI-enabled medical devices in real-world clinical settings to help the FDA ensure such medical devices remain safe and effective throughout their life cycle. This move underscores the FDA’s increasing focus on post-market oversight of AI technologies, including generative AI, and their evolving behavior in dynamic healthcare environments.
In particular, the FDA is seeking insight in the following areas:
- Post-Deployment Performance: The FDA is particularly interested in how AI-enabled devices perform after deployment, especially in response to factors such as data drift, changes in clinical practices, and shifts in user interaction patterns.
- Metrics and Methodologies: The FDA is seeking input on the metrics, tools, and methodologies used to assess safety, effectiveness, and reliability, including approaches for detecting and addressing performance degradation.
- Data Sources and Quality: Stakeholders are invited to provide insights on the use of data sources like electronic health records, device logs, and patient-reported outcomes, and strategies to manage data quality and ensure interoperability.
- Clinical Usage and Design: Feedback is requested on how clinical usage patterns influence device performance and what design or training strategies are effective in ensuring the devices continue to operate safely over time.
- Best Practices and Privacy: The FDA is encouraging discussion on best practices for real-world validation, privacy safeguards, and operational challenges encountered during the implementation and monitoring of AI devices in clinical settings.
Developers, manufacturers, healthcare providers, and digital health platforms are urged to contribute their insights to help shape the regulatory landscape. Click here for more information and submission guidelines. All comments must be submitted through www.regulations.gov by December 1, 2025.
For assistance preparing a comment submission or to discuss implications for your organization, please contact the author, the Garfunkel Wild attorney with whom you regularly work, or contact us at [email protected].