Mike on Medtech: CDRH 2021 Priorities

Mike on Medtech: CDRH 2021 Priorities

Mike Drues and Sean Fenske discuss several of the priorities the agency has been talking about recently and why they are important.

By Sean Fenske, Editor-in-Chief01.08.21
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 templates
    • Decentralized clinical trials with CDER and CBER
    • Feedback from patients through new Collaborative Communities forum
    • Digital Health Center of Excellence
  • How 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 sfenske@rodmanmedia.com 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.

Click here to review other podcasts.