CDRH 2021 Priorities

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 episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com.