In line with the current Administration’s key priorities to harness artificial intelligence (AI) to bring innovative medicinal products to market more quickly, the US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
The discussion paper, ‘Considerations for the Regulation of Generative AI-Enabled Medical Devices’, aims to collect early feedback from external stakeholders and support wider discussion on the issue. It provides an early indication of which GenAI characteristics the FDA think may require additional or adapted regulatory considerations across the medical device lifecycle. The purpose is not to describe the FDA’s Center for Devices and Radiological Health (CDRH) proposed or final regulatory expectations.
Key terms used include ‘GenAI-enabled device’, which is used to describe a product that contains one or more device software functions that are enabled by GenAI. A ‘GenAI-enabled device software function’ is defined as a device software function that is enabled by GenAI.
The paper covers the following topics and lists specific questions on each of the following topics:
- Considerations for the assessment of risk for GenAI-enabled medical devices
- Considerations for pre-market evaluation of GenAI-enabled medical devices
- Post-market monitoring for GenAI-enabled medical devices
- Other topics relevant to the regulation of GenAI-enabled medical devices
‘Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly’, said Acting FDA Commissioner Kyle Diamantas, JD. ‘Today’s announcement reflects the FDA’s commitment to advancing innovation for healthcare professionals and leveraging AI to improve care and patient health outcomes.’
The consultation deadline is 19 October 2026. Comments and responses to this discussion paper can be posted here.
