FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices

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FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices     On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Per the FDA’s announcement, the draft guidance …

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