The Food and Drug Administration (FDA) has announced the availability of draft guidance for devices that use artificial intelligence (AI)-enabled software functions. This draft guidance, once finalized, will give recommendations for what should be included in marketing submissions, focusing on safety and effectiveness. It suggests a total product lifecycle (TPLC) approach, which considers the design, development, and implementation stages of AI-enabled devices. Public comments on this draft are sought to ensure that FDA’s guidance aligns with the fast-evolving field of AI and adequately addresses performance and risk concerns.
Simple Explanation
The FDA is telling people about new suggestions for how to safely use and sell smart computer programs that help medical devices work. They want to make sure these smart tools are safe and want to hear what everyone thinks about their ideas.