FDA drafts AI-enabled medical device life cycle plan guidance

FDA drafts AI-enabled medical device life cycle plan guidance

The agency says it is proposing a science-based approach to requirements for medical devices powered by artificial intelligence and machine learning that would help deploy new devices faster. The Food and Drug Administration announced the release of draught advice that offers suggestions on life cycle controls in applications to market software functionality for machine learning-enabled devices. The FDA proposes to ensure that AI/ML-enabled devices "can be safely, effectively and rapidly modified, updated, and improved in response to new data" in the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," according to Brendan O'Leary, deputy director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health. According to the FDA, businesses must also explain how users will be informed clearly about updates in the PCCP.




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