Advancing Digital Endpoints

Michael McKnight, PhD

Dr. Michael McKnight joined the FDA’s Center for Devices and Radiological Health (CDRH) in 2020, where he leads scientific and regulatory review of a variety of neurodiagnostic devices, including a number of digital health technologies and software as a medical device (SaMD) products. His primary focus involves review of pre-market regulatory submissions, including 510(k)s, De Novos, and Pre-Submissions, as well as post-market reviews, including recall and allegation reviews. Dr. McKnight also assists with reviewing the use of digital health technologies in clinical trials for other FDA centers. Prior to joining FDA, he gained relevant product development experience as a software systems engineer and sensor design engineer in industry. Dr. McKnight received his PhD in Electrical Engineering from North Carolina State University, where his research focused on integrated bionic microsystems and textile-based wearable monitoring.