FDA Updates List of US Facilities That Perform COVID-19 Testing As of March 23

These FAQs can be found here. 

The “FAQs” identify the names of laboratories that are offering testing under the Emergency Use Authorization (EUA) process established by the Agency previously. In addition, FDA provides a list of the States that have notified the Agency that they are authorizing such testing in laboratories within their States. These states are Maryland, Nevada, New York, and Washington. Finally, the “FAQs” identify the commercial manufacturers who are distributing COVID-19 diagnostic test kits as well as those who have notified the FDA that they are now conducting serology tests.

Please see an earlier Arent Fox Alert which discusses these different testing approval mechanisms and regimens.

Previously we reported that CMS issued a second billing code for CMS testing. The lists provided are accurate as of March 23, 2020. Unfortunately, the FDA notes in its “FAQs” that it has not authorized any tests that are available for testing at home.

If you need further information on the tests that are available, or if you have questions on how to obtain FDA approval of a particular test, please contact the Food, Drug, Medical Device & Cosmetic group at Arent Fox.