FDA Is Turning Its Attention to Generative AI, Digital Health Companies Should Too

In August, the FDA released a discussion paper asking for public input on how generative AI-enabled medical devices should be evaluated and monitored. The paper covers four key areas: risk assessment, premarket evaluation, post market monitoring, and other emerging regulatory considerations.

Since then, the FDA has taken additional steps on AI. On September 4, the agency updated its AI-enabled medical device list and said it plans to explore ways to better identify devices incorporating foundation models, including large language models and multimodal architectures.

Then, on September 8, HHS announced the selection of Jared Seehafer as FDA's first Deputy Commissioner for Technology and Artificial Intelligence. The newly created position will lead FDA-wide strategy and priorities involving technology, software, and AI.

Taken together, these developments suggest AI policy is becoming a more significant part of FDA's broader strategy.

What The FDA Is Considering

Generative AI presents challenges that are different from traditional software. These systems can generate new content, rely on foundation models, and increasingly incorporate more autonomous or "agentic" capabilities.

The paper considers a possible competency-based approach to evaluating these products. Its strategy would combine non-clinical benchmarking with clinical confirmation to determine whether a device performs as intended before reaching patients. The agency is also considering risk-proportionate monitoring after products enter the market.

Why Digital Health Companies Should Pay Attention

For companies developing generative AI-enabled healthcare products, this is an opportunity to engage while federal policy is still taking shape.

Comments on FDA's discussion paper are due October 19, 2026, and can be submitted here. Companies can use the process to provide real-world perspectives on how these technologies are developed, tested, deployed, and monitored. Further allowing companies to anticipate where emerging regulatory approaches could either support or complicate innovation.

The FDA is not only asking how generative AI should be regulated. It is building internal leadership, updating its AI infrastructure, and asking industry to help shape what comes next.

For digital health companies, now is the time to pay attention and have a voice in the conversation.