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 are now regulated by FDA (CDER). FDA partnered with regulatory authorities from other countries/regions to create the International Medical Device Regulatory Forum (IMDRF) which is a risk-based approach to determine validation guidance, quality systems, and clinical requirements for SaMD products.