The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.
The guidance, if finalized, would be the first to cover AI devices from design and development to post-market monitoring and risk management, according to a Jan. 6 news release from the agency.
The guidance highlights key areas, including strategies to address transparency, bias and performance monitoring.
The FDA has authorized more than 1,000 AI-enabled medical devices and the new guidance builds on previous efforts.