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. In 2021, FDA published the AI and Machine Learning Software as a Medical Device Action Plan, which outlines FDA’s approach to regulating AI/ML technologies and next steps in furthering oversight, as well as the Good Machine Learning Practice for Medical Device Development: Guiding Principles, to inform the development of Good Machine Learning Practice. FDA also released a database of AI/ML-enabled medical devices currently marketed in the United States and will update this list as FDA reviews and authorizes additional AI/ML-enabled medical devices going forward.
Bethany Hills, Partner and Co-Chair of our MoFo FDA Regulatory and Compliance Practice outlines the AI trends for 2022 in our MoFo Tech blog. Read more.