Medtech POV Podcast with Scott Whitaker | FDA’s Dr. Jeff Shuren Says Agency Should “Re-envision” Medical Device Regulatory Framework

WASHINGTON, D.C. – Dr. Jeff Shuren, the head of FDA’s medical device division, told a medtech audience on a podcast released this week that the agency should “re-envision” the medical device regulatory framework. Dr. Shuren recently appeared on the newly launched Medtech POV podcast hosted by AdvaMed President and CEO Scott Whitaker.

“I really appreciate Dr. Shuren for taking time out of his busy schedule to speak to our audience about the important work our industry does to save lives, and the key role the CDRH plays in ensuring medical device safety and efficacy,” said Whitaker. “The Covid-19 crisis, as we discussed in the podcast, really highlighted the key role the medical technology industry plays in our healthcare system, and our work with CDRH and FDA more broadly certainly taught both the industry and regulators some key lessons we will learn from and implement going forward. It was great to be able to get into these issues with Dr. Shuren.”

In elaborating on efforts by the Center for Devices and Radiological Health (CDRH) toward re-imagining its approach, Shuren said, “The [regulatory] framework we use today was designed over 40 years ago. It was literally developed with my grandmother’s technology in mind, not for the things we see today. We should really sit down and re-envision what that framework should look like. This isn’t about changing the U.S. standard for reasonable assurance of safety and effectiveness. It’s about how we meet that standard in today’s world with today’s advances.”

The comments were made as part of a wide-ranging conversation on everything from the medical technology industry’s pivotal role in the U.S. pandemic response to lessons learned by both CDRH and FDA to be applied going forward when it comes to strengthening the public-private partnership to better meet patients’ needs.

Shuren and Whitaker discussed the key role CDRH and FDA play in protecting and promoting public health as the federal agency in charge of medical device regulation, as well as the challenges and opportunities currently facing the medtech industry as the nation emerges from the COVID-19 crisis.

When reflecting on the positive outcomes that come from public and private partnerships, he added, “The value isn’t just simply getting people together to deal with an issue. You build trust, you build understanding between the players. We will build those bridges, and it’s those bridges that ultimately allow folks to break down the barriers and start talking and communicating and impacting in a very positive way.”

The conversation also focused on the progress the industry has made over the past decade. “I think over the course of the last ten years, the pace, the speed and the innovation that has occurred in the medical device and technology field has really been historic,” noted Whitaker. “The number of things we’ve accomplished in the last 10 years versus the previous 50 years is remarkable.”

To listen to the full episode, visit the Medtech POV podcast on Spotify, Apple Podcasts or other podcast streaming platforms. For more information on the podcast and past guests, click here.

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world’s largest medical technology association. It premiered in in April 2021 and has featured medtech and health care policy leaders such as Dr. Steven Hahn and General James Mattis. In each episode, guests and host Scott Whitaker cover the intersection of medtech and policy from every perspective, including current issues in business, policy and current events.

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 AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.