SARA Expert Round: Our Answer to FDA on Generative AI-Enabled Medical Devices
FDA is asking. SARA will answer.
On 18 August 2026, FDA's Digital Health Center of Excellence published the discussion paper "Considerations for the Regulation of Generative AI-Enabled Medical Devices" and opened docket FDA-2026-N-7874. It contains 26 discussion questions. Comments close on 19 October 2026.
FDA rarely asks this openly what it should do. We think SARA is the right group to answer: practitioners who have been on the manufacturer side of FDA submissions, not just read about them.
What we're doing An online expert round with SARA members, each with hands-on FDA experience. We work through the questions together, take a real position on each one, and turn the result into a single response that we submit in SARA's name before the deadline.
Plan for 1 hour of focused discussion. Topics and questions are prepared in advance, so everyone comes ready.
A taste of what we'll dig into
The two-axis risk framework: do we understand it, and does it capture what actually makes a GenAI function risky?
PCCP logic: how does a Predetermined Change Control Plan hold up when future modifications can't be specified?
Third-party foundation models: the model can change without the manufacturer's involvement, and FDA asks how manufacturers detect, evaluate and respond. What is a defensible answer?
Plus risk assessment, premarket evaluation, postmarket monitoring and agentic AI
How to join Register on this page. We confirm the panel manually to keep the group small enough for a real discussion.
Join SARA on LinkedIn: https://www.linkedin.com/groups/26330047/