WASHINGTON—AdvaMed, the Medtech Association, encouraged the U.S. Food and Drug Administration (FDA) to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices rather than create new frameworks that could impede the innovations serving patients. The comments respond to FDA’s discussion paper (Docket No. FDA-2026-N-7874) seeking early input on assessing risks and evaluating GenAI devices before marketing and post-market monitoring.
AdvaMed supports targeted adaptations to address novel risks while maintaining device safety and effectiveness standards.
“The utilization of GenAI in medical devices should not fundamentally alter the core principles that have long governed medical device regulation,” wrote Geeta Pamidimukkala, AdvaMed vice president of technology and regulatory affairs, and Zack Hornberger, associate vice president of digital health and imaging technology.
“The existing risk-based premarket and postmarket frameworks are designed to support innovation and novel technologies in medical devices while ensuring device safety and effectiveness. When technology introduces novel considerations, existing frameworks and principles can be adapted in a targeted and risk-proportionate manner, rather than creating separate technology-specific regulatory frameworks or taxonomies. This approach preserves regulatory predictability, promotes global convergence, and ensures that oversight remains centered on the clinical risks and benefits of the device rather than a specific technology.”
AdvaMed recommends that FDA:
- Build on existing regulatory foundation and consensus-based best practices. FDA “should leverage and, when necessary, adapt premarket evidentiary expectations, methods, and terminology rather than creating new parallel expectations and vocabularies specific to GenAI.”
- Fully leverage the Predetermined Change Control Plan (PCCP). PCCPs describe planned device modifications and how they will be evaluated. FDA’s current approach “may be too restrictive to achieve its full potential” for GenAI use cases.
- Keep monitoring risk-based. FDA “should avoid prescribing a uniform postmarket monitoring approach” that increases burdens on a target technology rather than on identified risk.
About AdvaMed: AdvaMed, the Medtech Association, is the world’s largest association representing manufacturers of medtech and health tech.
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