FDA Regulatory Overview for Artificial Intelligence / Machine Learning /Software as a Medical Device (SaMD)

BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with Artificial Intelligence/ Machine Learning or Software as a Medical Device (SaMD).

Software as a Medical Device (SaMD) is a relatively new area of medical devices that is now regulated by the FDA Center for Devices and Radiological Health (CDRH).  FDA partnered with regulatory authorities from other countries/regions to create the International Medical Device Regulatory Forum (IMDRF) which develops a risk-based approach to determine validation guidance, quality systems and clinical requirements for SaMD products.