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FDA draft guidance on AI/ML in Healthcare

FDA’s Draft Guidance and Webinar on AI/ML in Healthcare

Regulatory Affairs

The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”. This draft guidance proposes a novel and flexible regulatory approach for AI/ML-based medical devices, inviting public comments until July 3, 2023. A significant tool that can help in…

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