The Food and Drug Administration will allow some COVID-19 test developers to market their products for at-home use without first studying how well the tests work on non-symptomatic patients.
The FDA announced Tuesday in a statement that it intends to streamline the use of tests and make it easier to conduct widespread testing, not only at homes but also in schools and offices.
“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” FDA medical device Director Jeff Shuren and diagnostics Director Tim Stenzel said in the statement.
The FDA also released a template for developers to use to help detect the virus in the asymptomatic patients, or those infected with the virus but showing no symptoms.
“In light of the evolving science and the administration’s interest in facilitating the establishment of testing programs by schools, communities, and other locations, and expanding access to at-home tests, we the FDA are providing additional options for test developers to get authorized screening claims,” an FDA official told POLITICO.
The FDA hopes that repeated testing over time will improve the accuracy of COVID-19 diagnosis.
Companies will be able to apply for permission to market their over-the-counter Coronavirus tests. However, it is unclear when this will take effect.
Source: Just The News