Category: Software as Medical Device – SaMD

US FDA Final and update guidances – Software

Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance details the changes to existing guidance documents that relate to the regulation of the software functions. As such, the FDA updated the following final […]

USFDA – Review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices Artificial Intelligence and Machine Learning in Software as a Medical Device Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)