Regulation and official guidance
U.S. Food and Drug Administration
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…
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)…
