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The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices.
The document – 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 agency said in a statement Tuesday.
WHY IT MATTERS
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. 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.
“Because modifications that are specified and implemented in accordance with an authorized PCCP were reviewed and authorized through the marketing submission containing the PCCP, the modifications can be implemented to the AI-DSF without triggering the need for a new marketing submission,” FDA said in its final guidance posted in the Federal Register.
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 agency will host a webinar on January 14, 2025, for industry and others to learn more about the final guidance, according to its announcement.
THE LARGER TREND
The agency has said that while it is committed to deploying new devices faster, it will take a science-based approach to its requirements for medical devices powered by AI and ML.
The agency considered how to avoid multiple submissions for technology expected to evolve and streamline the ongoing regulatory review process for developers across medical device life cycles.
The draft guidance considered performance concerning race, ethnicity, disease severity, gender, age and geographical considerations in the ongoing development, validation, implementation and monitoring of AI/ML-enabled devices, according to Brendan O’Leary, deputy director of the Digital Health Center of Excellence in the FDA’s Center for Devices and Radiological Health, in the agency’s March announcement opening a public comment period.
ON THE RECORD
“The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways,” FDA said on its website.
“The recommendations in this guidance build on FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.”
Andrea Fox is senior editor of Healthcare IT News.
Email: af**@***ss.org
Healthcare IT News is a HIMSS Media publication.
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