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.
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Have You Heard? Hearing Aids Are Now Available Over The Counter
US consumers have OTC access a year after FDA proposed category. While OTC category is limited to devices designed for mild to moderate hearing loss and not more severe hearing impairment, it covers vast majority of consumers with hearing loss.
FDA Device User Fees Climb For FY2023
The US Food and Drug Administration has announced higher user fees for FY2023, with most fees jumping about 18% while 510(k) fees saw an eye-popping 56% increase.
FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs
As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.