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FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Life Sciences, Biotechnology & Nanotechnology

On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"...
White House District Of Columbia United States Software Functions Submission Recommendations Predetermined Change Control Plan
Source: mondaq.com

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