How the FDA Is Using AI in Regulatory Review

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How the FDA Uses AI in Device Review

The FDA AI in device review process is evolving fast—and it may transform how regulatory teams navigate medical device submissions. In this episode of MedDevice by Design, we explore how the FDA is using artificial intelligence internally to accelerate 510(k) reviews, improve predicate searches, and streamline labeling and documentation checks.

FDA’s Internal AI Tools Are Expanding

The FDA has already appointed a Chief AI Officer and is developing internal tools, including a large language model rumored to be in collaboration with OpenAI. Starting in June 2025, these tools are expected to be rolled out across departments. These technologies are designed to support internal staff—not replace them.

Faster Reviews for Common Device Submissions

Class II devices such as blood pressure monitors and surgical gloves may benefit the most from FDA AI in device review workflows. By using trained AI models, reviewers can automate routine predicate searches, validate labeling against regulatory standards, and identify missing traceability in submission documents.

Why This Matters for Regulatory Professionals

While novel and high-risk devices will still require close human evaluation, AI promises to reduce the review burden for standard submissions. This allows regulatory and engineering teams to focus more on innovative product development. Instead of spending weeks preparing repetitive documentation, they can rely on automated feedback to guide improvements faster.

What Comes Next?

There’s still a lot we don’t know, but the FDA is clearly signaling that AI will be part of the future of regulatory review. The ability to streamline standard 510(k) submissions could help improve speed, consistency, and predictability in approvals—benefiting both regulators and medtech innovators.

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