AI/ML-Based Software as a Medical Device (SaMD)
One of the greatest benefits of AI/ML in software resides in its ability to learn from real-world use and experience, and its capability to improve its performance.
FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive. An Action Plan was developed and published in January 2021 building on the Agency’s longstanding commitment to support innovative work in the regulation of medical device software and other digital health technologies.