The Food and Drug Administration is aiming to help developers of artificial intelligence-enabled medical devices understand the agency's mindset around the technology.
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of their AI-enabled medical device. If finalized, it would be the first guidance from the FDA to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle.
Related: What’s ahead for AI regulation in 2025?
The draft guidance comes as development of healthcare AI continues to pace ahead of the industry's ability to regulate the technology. Last month, a bipartisan task force in the House issued a comprehensive report outlining policy recommendations. Congressional leaders from both the Senate and House of Representatives have conducted hearings to learn how insurers and providers use AI, but they have not passed significant legislation to regulate it.
The guidance would offer developers an accessible set of considerations that would assist in the development, maintenance and documentation of AI-enabled medical devices. It also would include the FDA's thinking on how developers should address transparency and bias throughout this life cycle.
To date, FDA has authorized more than 1,000 AI-enabled medical devices via pre-market pathways. Troy Tazbaz, director of the FDA’s digital health center of excellence, said in a news release guidance brought together shared insights from already authorized AI-enabled devices.
The agency requested public comment on the draft guidance by April 7.
