Our FDA team recently published an Insight covering key considerations for artificial intelligence (AI) healthcare application developers and users, highlighting the FDA’s current regulatory scheme for AI/machine learning (ML)-based software, potential FDA enforcement discretion that may apply, and recent FDA developments impacting AI/ML technologies. This Insight may be of interest to clients and friends of Health Law Scan.
For readers looking for these insights in greater detail, please visit the event page for the AI Boot Camp webinar, Software as a Medical Device: US FDA Regulatory and Legal Framework, for additional resources, including the event recording and materials.