Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 | FDA

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 | FDA

Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports. 

It is not the FDA’s role to develop tests or decide what tests a health care professional uses. Our role is to determine if the tests developed by others provide accurate and reliable results, even when some would prefer that we let tests on the market without evidence that they work. It’s critical that the tests used work. False results can also contribute to ...