COVID-19 widespread testing is crucial to fighting the pandemic, but is there enough testing? The answer is in the positivity rates.
Even as advocates cite bureaucratic red tape blocking fast and cheap home coronavirus tests, the federal government’s regulatory agency overseeing testing says it will be flexible and encourage developers to seek approval.
The Food and Drug Administration issued a document on July 29 calling for home tests to correctly identify the virus at least 90% of the time. But a high-ranking FDA official overseeing testing told USA TODAY the agency will consider tests with lower sensitivity.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the agency’s recommendations issued more than two months ago are “starting points.”
“Our door has been open, and we’re very flexible because we’re trying to do all we can, at least from an FDA side, to have