In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). GMLP supports the development of safe, effective, and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance.
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed…
