The US Food and Drug Administration announced the availability of final guidance on artificial intelligence medical devices.
The document – Marketing Submission Recommendations for a Pre-Determined Change Control Plan for Software Features of AI-Enabled Devices – aims to provide a “forward-looking approach to promote the development of safe and effective AI-enabled devices,” the agency said in a statement. statement Tuesday.
WHY IT’S IMPORTANT
The guide provides recommendations on what information to include in a marketing application for a device that has one or more AI-enabled device software features. The FDA has stated that for modifications to artificial intelligence-enabled device software features (AI-DSF) that are expected to occur over time, an entirely modern product launch will not be required.
“Because the modifications identified and implemented in accordance with the approved PCCP document have been reviewed and approved as part of the marketing application containing the PCCP, the modifications can be implemented in the AI-DSF without the need to submit a new marketing application,” the FDA said in its final guidance published in the Federal Register.
Instead, the agency said it would focus modification reviews “on those aspects of the device that undergo the most significant changes” and suggested submitting documents containing tracked changes.
According to the announcement, the agency will host a webinar on January 14, 2025 for industry and others to learn more about the final guidance.
A BIGGER TREND
The agency said that while it is committed to faster rollout of modern devices, it will apply a science-based approach to its requirements for medical devices that apply artificial intelligence and machine learning.
The agency considered how to avoid multiple submissions for technology that is expected to evolve and streamline the ongoing regulatory review process for medical device developers at all stages of a medical device’s lifecycle.
According to Brendan O’Leary, deputy director of digital technologies, the draft guidance incorporates findings on race, ethnicity, disease severity, gender, age and geography into the ongoing development, validation, deployment and monitoring of Health Center AI-enabled devices of Excellence in the FDA’s Center for Devices and Radiological Health, in the agency’s March announcement opening the public comment period.
ON RECORDING
“The recommendations in this guidance apply to artificial intelligence-enabled devices, including device components of complex device-based products verified under the 510(k), De Novo, and PMA pathways,” the FDA said on its website.
“The recommendations in this guidance build on FDA’s long-standing commitment to developing and applying innovative approaches to regulating artificial intelligence-enabled devices.”