On February 29, 2020, FDA issued the immediately in effect guidance titled Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.1
On Friday, March 6, 2020, at 1:00 pm ET, FDA will host a virtual town hall for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that are developing or have developed molecular diagnostic tests for SARS-CoV-2. The purpose of the town hall is to help answer technical questions about the development and validation of molecular tests for SARS-CoV-2 and the recently issued guidance. Registration is not necessary.
- Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff. Silver Spring, Md: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, FDA, 2019. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia-prior. Accessed March 3, 2020.