FDA action plan puts focus on AI-enabled software as medical device
Summary
The U.S. Food and Drug Administration this week published its first action plan for how it intends to spur development and oversight of safe, patient-centric artificial intelligence and machine learning-based software as a medical device. • Developing new methods to evaluate and improve machine learning algorithms, As for a more tailored regulatory approach, FDA says it will update the proposed framework for AI/ML-based SaMD, "including through issuance of Draft Guidance on the Predetermined Change Control Plan." The agency notes that "promoting transparency is a key aspect of a patient-centered approach, and we believe this is especially important for AI/ML-based medical devices, which may learn and change over time, and which may incorporate algorithms exhibiting a degree of opacity." Speaking this past October at the Center of Excellences Patient Engagement Advisory Committee, Patel said AI is at a pivotal moment where "software can take inputs from many, many, many sources and generate those intentions for diagnosing, treating. ON THE RECORD Bradley Merrill Thompson of the law firm Epstein Becker & Green – where he counsels on medical devices, FDA regulatory issues and more – offered his thoughts on the action plan to HITNs sister publication MobiHealthNews.