In response to the latest data on COVID-19 antigen test performance regarding how repeat testing improves the accuracy of such tests, the FDA revised the Emergency Use Authorizations (EUAs) of all such tests on Nov. 1.
According to an FDA letter sent on this date, the revisions, which update the approved use of COVID-19 antigen tests, also now require test makers to make updates to the labeling of their products to include information about the new uses.
COVID-19 antigen tests that have currently been granted EUA are now authorized:
- To be used for serial testing “at least twice over three days” for people who have COVID-19 symptoms
- To be used for serial testing “at least three times over five days” for those without COVID-19 symptoms
For the new Condition of Authorization relating to labeling, the FDA states that test developers will need to:
- Submit their “proposed updated labeling” to the FDA within 10 days of Nov. 1 “as a supplement” to their EUA, unless they come to a different agreement with the agency’s Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In Vitro Diagnostics /Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH)
- Once the FDA approves the new labeling, test makers will need to make the required changes to their products’ electronic/mobile applications and electronic labels within 20 business days and update their paper labels within 30 days
- All antigen tests distributed after the paper labels are updated must include the new paper labels
According to the FDA, the revisions do not apply to EUAs for the following COVID-19 tests:
- Non-antigen based authorized assays
- Authorized IL-6 assays
- Standalone specimen collection devices
- Standalone home collection kits