Devices

AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI

The medical device industry is urging federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient care, warning that new or duplicative regulatory frameworks could slow innovation and delay access to AI-enabled technologies.

In a comment letter responding to a federal request for information on accelerating AI adoption in clinical care, AdvaMed told HHS that FDA should remain the “sole regulator” of AI-enabled medical devices and software functions that meet the definition of a device under federal law.

The letter was submitted to the Office of the Assistant Secretary for Technology Policy and the Office of the National Coordinator for Health Information Technology as part of HHS’ effort to identify policy changes that could promote broader integration of AI tools across hospitals and physician practices.

AdvaMed’s comments focus heavily on the need for predictable and transparent FDA pathways for AI-based products, particularly those that learn or evolve.

The group called for greater consistency in the De Novo classification process for novel AI technologies and broader use of Predetermined Change Control Plans (PCCPs), which allow manufacturers to pre-specify certain algorithm modifications without triggering a new premarket submission. According to AdvaMed, expanded use of PCCPs is critical to enabling continuous improvement of AI models while maintaining appropriate oversight.

The organization also urged FDA to draw clearer distinctions between advanced adaptive AI systems and more traditional software-based decision support tools, arguing that overly broad or ambiguous guidance could impose unnecessary compliance burdens.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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