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.
Enjoying MedDevice by Design? Sign up to get new episodes sent to your inbox.
Related Resources
The FDA agentic AI is making headlines after the agency announced its own internal AI review tool. In this episode of MedDevice by Design, Ariana and Mark discuss what this could mean for medical device submissions and regulatory efficiency.
The sandwich ELISA assay is one of the most common ELISA formats used in diagnostics. Nick and Nigel walk through the method step by step using simple visuals and plain language.
For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.
When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.