Premier Weighs in on FDA Oversight of Generative AI-Enabled Medical Devices

Premier submitted comments to the Food and Drug Administration (FDA) in response to its discussion paper on the regulation of generative AI-enabled medical devices. FDA sought stakeholder feedback on a potential competency-based approach to premarket evaluation and greater reliance on postmarket monitoring for these devices, given the challenges with assessing AI-enabled devices using traditional methods. The discussion paper does not represent proposed or final FDA guidance or policy.

In its comments, Premier supports efforts to responsibly use AI while emphasizing the need for appropriate safeguards throughout a device’s lifecycle. Premier recommends that FDA:

• Require representative evidence: Manufacturers should demonstrate that benchmark data reflect the patient populations and care settings where devices will be used and use multi-site, real-world data when feasible.
• Maintain manufacturer accountability: Independent third parties could support evidence generation and evaluation, but manufacturers should remain responsible for device safety and effectiveness.
• Tie premarket flexibility to strong postmarket oversight: Any reduction in premarket clinical evidence should depend on enforceable postmarket monitoring that is funded and controlled by the manufacturer.
• Monitor performance over time: FDA should consider periodic re-benchmarking, clinician review, performance-degradation monitoring and multi-site comparisons.
• Prioritize event-driven monitoring: Material performance changes should trigger review, supplemented by risk-based periodic assessments, with healthcare institutions receiving timely notification of material device or model changes.
• Clearly define responsibilities: Healthcare stakeholders may help observe and report performance, but manufacturers should retain responsibility for monitoring the safety and effectiveness of their devices.

Premier also recommends using qualified, independent third parties where appropriate while preserving FDA’s role in determining whether a medical device is safe and effective.