FDA Publishes Good Machine Learning Practices Guide For Medical Device Manufacturers
WASHINGTON—In conjunction with Health Canada and the United Kingdom's Medicines and Healthcare Products Regulatory Agency, the U.S. Food and Drug Administration (FDA) has published 10 guiding principles for Good Machine Learning Practice in the development of medical devices. The principles are intended to promote development of safe and effective medical devices that use artificial intelligence and machine learning.
The document is one of the deliverables laid out in the FDA's AI/ML software as a medical device (SaMD) action plan issued in January as it looks to establish a regulatory approach to the fast-developing field. FDA framed the principles as a starting point for international harmonization and is seeking feedback as part of its broader discussion of the regulatory framework for modifications to AI/ML-based SaMD.