Patients, providers and medtech firms submitted hundreds of comments to the Food and Drug Administration on how the agency should approach generative AI in medical devices.

Hundreds of patients, physician groups and medical device firms weighed in as the Food and Drug Administration prepares to develop guidance on generative artificial intelligence.

The FDA sought comments in response to an August discussion paper, in which it proposed evaluating generative AI-enabled devices using a framework inspired by physician credentialing and emphasized the importance of postmarket monitoring.

Generative AI can create text, images, and code, but it is difficult to evaluate because its outputs may vary and its performance can change over time.

By the time the comment period closed in mid-October, the FDA had received more than 500 submissions.

Commenters brought contrasting viewpoints, with a prominent medtech lobbyist calling for the FDA to keep its existing regulatory framework, while physicians and patients called for more postmarket monitoring and stronger safeguards against consumer chatbots that may give faulty health advice. Hospitals and provider groups also emphasized that developers, not doctors, should be responsible for these devices’ safety and performance.

The medtech lobbyist wants the FDA to build on its existing regulatory framework rather than create a new framework specific to generative AI-enabled devices. AdvaMed broke down its expectations into three parts:

It wants the FDA to use existing premarket expectations for generative AI devices. The inclusion of generative AI in a medical device should not automatically trigger a competency assessment, AdvaMed wrote in its comments.

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