Machine Learning Best Practices – USA, Canada, and UK Propose 10 Guiding Principles

November 22, 2021

Machine learning and artificial intelligence-based medical devices are being approved with increasing frequency but lack established best practices. As a result, the US Food and Drug Administration (FDA), the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and Health Canada proposed ten principles to guide the industry and global health organizations in developing Good Machine Learning Practice (GMLP).

According to the FDA, “The 10 guiding principles identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP. Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines.”

Read more about the 10 guiding principles here.

(Source: US Food and Drug Administration, October 27th, 2021)

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