FDA Policy for Diagnostic Tests for COVID-19
In order to achieve rapid testing for COVID-19, the Food and Drug Administration is shifting some responsibility to states and providing more specific details for commercial and laboratory manufacturers. The FDA is adapting as the situation evolves.
States can now be responsible for tests developed and used by laboratories in their states, according to a new FDA policy announced March 16. Each state can set up a system for authorizing COVID-19 tests and the laboratories will not engage with the FDA. These laboratories will not have to pursue and Emergency Use Authorization (EUA) with the FDA as long as the lab is compliant with regulations under the Clinical Laboratory Improvement Amendments of 1988.
The FDA does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. The new guidelines state that commercial test developers can launch an assay as soon as it is validated to previously guided standards, provided the companies subsequently pursue EUA within 15 days. The manufacturer must provide instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website.
The FDA has not yet authorized any at home test for COVID-19. The FDA is also actively and aggressively monitoring the market for any fraudulent COVID-19 diagnostic claims.
Prior to selecting a laboratory for COVID-19 testing, it is important to verify validation of the test, CLIA certification, as well as checking with your state's health department for guidance.