CDRH 2022: Shuren Says COVID-19 Left Agency ‘Battle-Scarred’ But Also Wiser

The Agency’s Annual Report Discussed Its Top Challenges And Accomplishments For The Year That Was

The US Food and Drug Administration’s device center released its annual report, noting the challenges posed by monkeypox on top of the ongoing COVID-19 pandemic. The report also cites what the center sees as its accomplishments for the year.

2022 Review
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As it transitions from emergency mode imposed by the pandemic back to a more stable pace of operations, the Food and Drug Administration’s device center says it had to deal a wide range of priorities amid the challenges of yet another public health emergency – monkeypox.

In a 2022 annual report released on 26 January, the agency’s Center for Devices and Radiological Health (CDRH) cites its pandemic response, the Medical Device User Fee Amendment (MDUFA)...

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