Artificial Intelligence and Machine Learning for In Vitro Diagnostics (AI/ML) is revolutionizing medical device development and is being leveraged in applications ranging from digital image analysis to in vitro diagnostics. Although it is expected that the number of AI/ML-enabled medical device products will increase exponentially in the future, there is currently no suitable regulatory framework for addressing the iterative improvements that can occur post-launch for AI/ML-enabled medical devices, including in vitro diagnostics, while ensuring their safety and effectiveness for their intended use. Such a regulatory framework would need to take into account numerous factors, such as the potential use of Real World Data (RWD), and the appropriate metrics to use to address the unique challenges posed by AI/ML applications used as software in a medical device (SiMD) and/or software as a medical device (SaMD).

The Medical Device Innovation Consortium’s AI/ML working group have drafted for public comment a framework document that will include the Glossary, SPS template, and ACP template, as well as additional background and context. An informational webinar on the framework and how to submit public comment will be held on Tuesday, February 1, 2022.