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USFDA Guidance: Predetermined Change Control Plans (PCCPs) for AI/ML Medical Devices
Artificial Intelligence and Machine Learning (AI/ML) are increasingly used in medical devices—from diagnostic imaging software to digital...

Sharan Murugan
1 day ago2 min read
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USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
The US Food and Drug Administration (USFDA) Â has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...

Sharan Murugan
Dec 9, 20242 min read
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