Agencies Issue Guiding Principles For AI/ML-Enabled Medical Devices
WASHINGTON—The U.S. Food & Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have jointly identified 10 guiding principles that can help manufacturers build safe, effective and high-quality medical devices that enable artificial intelligence and machine learning.
According to the FDA, the just-released principles should help "cultivate future growth in this rapidly progressing field.” The agency also hopes the principles help tailor practices from other sectors so they are applicable to medical technology and the healthcare sector.