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A Year Of Extraordinary Health Challenges: CDRH Annual Report

 
• By Brian Bossetta

In its 2021 annual report, the US FDA’s Center for Devices and Radiological Health outlines what it sees as list of accomplishments in a year director Jeff Shuren says was perhaps the busiest in the center’s history.

FDA HQ
• Source: Alamy

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) released its 2021 annual report highlighting several emergency use authorizations (EUAs) in “record time” for a variety of devices to address public health needs during the COVID-19 pandemic.

In the report, released 31 January, CDRH director Jeff Shuren says one way the center is tracking its success is...

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• By Amanda Maxwell

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Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.