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.
News We’re Watching: Biden Moves To Strengthen Supply Chain; More Medtech-Related Prosecutions; $5.5M Sepsis Grant For Siemens
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.