Alliance Comments on FDA Discussion Paper on Generative AI-Enabled Medical Devices
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. 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.