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FDA Publishes Draft Guidance For Predetermined Change Contro
FDA Publishes Draft Guidance For Predetermined Change Contro
FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Life Sciences, Biotechnology & Nanotechnology
On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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"...
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