FDA brought medtech up to speed on several key medical device programs during the CDRH Townhall at The MedTech Conference.

Daphne Allen

September 30, 2021

11 Slides

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, and his colleagues shared a number of key medical device updates during the annual CDRH Town Hall at The MedTech Conference by AdvaMed. The 2021 virtual session was moderated by Janet Trunzo, AdvaMed’s senior advisor to the president and senior executive vice president, technology and regulatory affairs.

“Our efforts push on two prongs—innovation and safety, which we believe are two sides of the same coin,” Shuren shared as he kicked off the session. He added that such work includes “derisking the entire product lifecycle such that the development of and investment in medical devices and the U.S. marketplace is far more attractive.”

Understandably, COVID-19 still is “the top effort underway at the center,” he said, adding that they’ve seen a "massive increase in submissions and a big increase in workload." For instance, in 2020, the center saw a 38% increase in submissions, and it has brought almost 1700 medical devices to authorization in the United States, he said. “Critical to that was the regulatory flexibility of EUAs and extensive engagement with developers,” he added.

Click through our slideshow for updates on key CDRH projects. And be sure to click through to the end for a flashback to last year's CDRH Townhall.

About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, materials, packaging, labeling, and regulatory issues for more than 20 years. She has also presented on these topics in several webinars and conferences, most recently discussing design and engineering trends at IME West 2024 and leading an Industry ShopTalk discussion during the show on artificial intelligence.

Follow Daphne on X at @daphneallen and reach her at [email protected].

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