U.S. Food and Drug Administration Archives - AI Standards Hub

U.S. Food and Drug Administration

Frameworks and principles

Predetermined change control plans for machine learning-enabled medical devices: Guiding principles

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Topic:

Risk management Safety

Domain:

Healthcare and medicine

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In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…

Organisation: Medicines and Healthcare products Regulatory Agency; U.S. Food and Drug Administration; Health Canada

Last Updated: 23 Jan 2024

Regulation and official guidance

Clinical decision support software: Guidance for industry and Food and Drug Administration staff

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Topic:

Bias Data collection

Domain:

Healthcare and medicine

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Organisation: U.S. Food and Drug Administration

Last Updated: 23 Jan 2024

Frameworks and principles

Good machine learning practice for medical device development: guiding principles

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Topic:

Accuracy and performance Data Ethical considerations Good practice for development and use Safety System quality

Domain:

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)…

Last Updated: 19 Dec 2022