FDA Doubles Test Review Staff, Is Prioritizing EUA Reviews For Home-Use And High-Batch Tests
A top FDA official said the agency has more than doubled its virology review staff to handle the cascade of EUA applications. He said the agency is prioritizing certain COVID-19 diagnostics during a recent webinar.
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Two QA/RA experts highlight hot-button topics that quality assurance and regulatory affairs professionals should keep an eye on in the medtech space this year.
As the number of emergency use applications (EUAs) for COVID-19 tests have mushroomed, the director of the US FDA’s in vitro diagnostics division says he’s directed his office to ensure all sponsors are assigned an agency liaison within two weeks of receiving a completed application. And if an officer isn’t assigned, Timothy Stenzel told sponsors to personally reach out to him so he can intervene on their behalf.
The US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.