Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), has mentioned in recent presentations. The agency had also laid out several priorities in a document a few years ago to be acted upon from 2018 through 2020, which has now been extended to 2021. Specifically, we address a number of questions, including:What are the important priorities for CDRH in 2021?Tracking of submissions and electronic templatesDecentralized clinical trials with CDER and CBERFeedback from patients through new Collaborative Communities forumDigital Health Center of ExcellenceHow will the COVID-19 pandemic impact these priorities and CDRH operations moving forward?What’s been the impact on non-COVID devices? Are new devices still being developed or being reviewed by the agency?What about the impact of politics and the new incoming administration?Listen to this