laws & regulations_CAIVD & PCEM

11 FDA Plans You Need to Know About

2021/10/8 11:50:24　Views：2789

Original from: mddionline

Author: Daphne Allen

Image Credit: JHVEPhoto – Adobe Stock

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 the following link to read the 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.

https://www.mddionline.com/regulations/11-fda-plans-you-need-know-about/gallery?slide=1

Source: 11 FDA Plans You Need to Know About

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