https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency?utm_campaign=2020-03-16%20COVID-19%20Diagnostics%20FDA%20Updates%20Policy&utm_medium=email&utm_source=Eloqua

FDA Updates Policy on COVID-19 Diagnostics

Today, the U.S. Food and Drug Administration (FDA) updated its policy issued on February 29, 2020, for laboratories and commercial manufacturers seeking to develop SARS-CoV-2 diagnostic tests in order to achieve more rapid testing capacity in the United States.

Read the Updated Policy Key Elements in the Updated Policy  To expand the number and variety of diagnostic tests, as well as available testing capabilities in health care settings, the FDA: Is allowing states to take responsibility for tests developed and used by laboratories in their states. 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 Is providing recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Questions? Email CDRH-EUA-Templates@fda.hhs.gov.