The Alliance for Connected Care submitted comments to FDA’s Center for Devices and Radiological Health (CDRH) and Digital Health Center of Excellence in response to the discussion paper Considerations for the Regulation of Generative AI-Enabled Medical Devices.

Our overarching position

FDA should preserve the existing statutory line between regulated medical devices and non-device software, and apply risk-based, proportionate oversight to GenAI-enabled functions that qualify as devices. Using GenAI should not, by itself, determine regulatory status. Oversight should reflect intended use, clinical consequences, autonomy, and the effectiveness of safeguards.

The Alliance:

  • Supports a function-based, risk-proportionate approach. Oversight should reflect intended use, autonomy, clinical consequences, and the effectiveness of safeguards, including meaningful clinician review, rather than the use of generative AI itself.
  • Urges FDA to evaluate GenAI in its intended clinical workflow, accounting for clinician participation, clinical protocols, escalation pathways, and other safeguards.
  • Cautions against conflating non-device AI-enabled care with regulated device functions. Care coordination, patient engagement, documentation, and administrative support should be assessed by their specific functions and statutory exclusions, not regulated simply because GenAI supports them. Functions that independently perform a regulated medical purpose should remain subject to FDA oversight.
  • Urges flexible, real-world evidence pathways that reflect the intervention’s actual risk.
  • Encourages weighing the broader implications of GenAI’s availability, including expanded access, relief for provider shortages, and fewer diagnostic errors. An imperfect capability must be weighed against a patient unable to access care.
  • Encourages clear delineation of shared responsibility between foundation model developers and device deployers, matched to each actor’s control over design, validation, implementation, monitoring, and risk mitigation.

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