Foundational Tools for Your Next AI/ML Technology

List of references to relevant materials:

Artificial Intelligence and Machine Learning (AI/ML) - Enabled Medical Devices →

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FDA FACT SHEET
The FDA’s Role in Medical Device Cybersecurity
Dispelling Myths and Understanding Facts →

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Principles and Practices for the Cybersecurity of Legacy Medical Devices
Medical Device Cybersecurity Guide →

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GUIDANCE DOCUMENT
General Principles of Software Validation
Guidance for Industry and FDA Staff →

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GUIDANCE DOCUMENT
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Guidance for Industry and FDA Staff →

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GUIDANCE DOCUMENT
Off-The-Shelf Software Use in Medical Devices
Guidance for Industry and Food and Drug Administration Staff →