Devices

Bipartisan Policy Center Comment on Generative AI Devices

David McFarland

— 1 min read
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The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points:

  • several approaches in the discussion paper will require new authority from Congress;
  • implementing the approaches will require sufficient FDA staffing and technical expertise;
  • risk assessment for generative AI should account for the expertise of the intended user and their ability to contextualize clinical information;
  • AI models may perform differently when they recognize they are being tested and thus benchmarking should be paired with some form of clinical confirmation, proportionate to risk; and
  • Greater reliance on postmarket monitoring will require shared infrastructure among health systems, manufacturers, and FDA, and more flexible change control plans.

The comment letter also responds to specific FDA questions involving considerations for assessing risk for generative AI-enabled devices, a competency-based approach for premarket evaluation of generative AI-enabled devices, and postmarket monitoring for generative AI-enabled devices.

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