Frameworks and principles
North America
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
Regulation and official guidance
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
Official policy proposals and consultations
Blueprint for an AI bill of rights
The Blueprint for an AI Bill of Rights is a guide for a society that protects all people from these…
Strategies and roadmaps
U.S. leadership in AI: a plan for federal engagement in developing technical standards and related tools
Strategies and roadmaps
Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan
The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action…
Official policy proposals and consultations
Federal automated vehicle policy
Frameworks and principles
Good machine learning practice for medical device development: guiding principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)…
