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    • Regulatory Consulting Services
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May 2023


FDA draft guidance on AI/ML in Healthcare

FDA’s Draft Guidance and Webinar on AI/ML in Healthcare

By Anne Arndt17 May 2023Leave a comment

The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 This draft guidance…

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