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# AdvaMed Urges FDA to Use Existing Regulatory Framework for GenAI
- URL: https://www.fdaweb.com/advamed-urges-fda-to-use-existing-regulatory-framework-for-genai/
- Published: 2026-10-27T21:22:00.000Z
- Updated: 2026-10-28T00:23:57.000Z
- Author: David McFarland
- Tags: Devices

AdvaMed is asking FDA to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices instead of creating new frameworks that could hinder innovation.

In [comments](https://www.advamed.org/wp-content/uploads/2026/10/10-19-2026-AdvaMed-Cmts-re-Dkt-No-FDA-2026-N-7874-GenAI-Discussion-Paper.pdf?ref=fdaweb.com) responding to an [FDA discussion paper](https://www.fda.gov/medical-devices/digital-health-center-excellence/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request?ref=fdaweb.com), AdvaMed said utilizing GenAI in medical devices “should not fundamentally alter the core principles that have long governed medical device regulation.” It said existing risk-based device premarket and postmarket frameworks are designed to support innovation and novel technologies.

“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,” the group contended. “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:

- FDA should expand on existing regulatory foundation and best practices. It “should leverage and, when necessary, adapt premarket evidentiary expectations, methods, and terminology rather than creating new parallel expectations and vocabularies specific to GenAI.”
- The agency should leverage the Predetermined Change Control Plan to describe planned device modifications and how they will be evaluated. It notes the current approach “may be too restrictive to achieve its full potential” for GenAI use cases.
- FDA should use risk-based monitoring principles. It “should avoid prescribing a uniform postmarket monitoring approach” that increases burdens on a target technology rather than on identified risk.