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# FDA Gives States Coronavirus Testing Authority
- URL: https://www.fdaweb.com/fda-gives-states-coronavirus-testing-authority/
- Published: 2020-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:07:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146345

FDA has updated a [policy](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency?ref=fdaweb.com) issued last month on diagnostic testing for coronavirus to expand the number and variety of diagnostic tests available in health care settings, and reference and commercial laboratories. The updated policy allows states to take responsibility for tests developed and used by laboratories in their states, similar to what FDA granted to the New York State Department of Health last week. “States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” an [agency release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help?ref=fdaweb.com) says. “Laboratories developing tests in these states can engage directly with the appropriate state authorities, instead of with the FDA. Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA.”

Additionally, FDA is expanding its policy to commercial manufacturers distributing and labs using new commercially developed tests to allow their use prior to the agency granting an EUA, under certain circumstances. “During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s Web site,” it says. The agency gives manufacturers 15 business days to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.