December 11, 2024- The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices, according to Healthcare IT News. The document, titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” aims to provide a “forward-thinking approach to promote the development of safe and effective AI-enabled devices,” the FDA said in a statement Tuesday.
The guidance offers recommendations on the information to include in a marketing submission for a device with one or more AI-enabled device software functions, according to Healthcare IT News. FDA said that for modifications to Artificial Intelligence-Enabled Device Software Functions, or AI-DSFs, which are expected over time, the agency will not require an entirely new market submission. Instead, the agency said it will focus modification reviews “on the aspects of the device that are most significantly modified,” and suggested submitting documents with tracked changes. The FDA will host a webinar on January 14, 2025, for industry and others to learn more about the final guidance, according to its announcement.