As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device Regulators Forum (IMDRF), a group of regulators, scientists, legal experts and physicians from the US, Canada, the European Union, Australia, China, Russia, and Brazil to pursue harmonization of the regulatory approach to standalone medical software.
