Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a.
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework.
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a.
Food and Drug Administration FDA released Good Machine Learning Practice for Medical Device Development: Guiding Principles developed in conjunction with Health Canada and the United Kingdom UK Medicines and Healthcare products Regulatory Agency MHRA.