Day: April 4, 2019

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)