Revising its Emergency Use Authorization (EUA) for COVID-19 testing policy May 11, the US Food and Drug Administration (FDA) expressed new awareness that “a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the [National Institutes of Health] NIH, indicating that greater FDA oversight of commercial serology tests is important to protect the public health.”
Full details of the FDA’s revised “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency” can be read on the FDA’s website, here.
Highlights of Revised FDA COVID-19 Testing Policy
- Commercial manufacturers are now required to submit an EUA for COVID-19 serology tests that are marketed and distributed.
- Commercial manufacturers can develop and distribute tests after validation while they are preparing an EUA for submission. The FDA considers 15 business days to be a reasonable time period for preparing an EUA submission and intends consequences should the request not be submitted within the timeframe.
- In circumstances where manufacturers use distributor(s) for their product, the manufacturers should identify the names of all distributors in their notification.
- Existing serology tests on the market by commercial manufacturers should already be validated, and the FDA considers 10 business days to be a reasonable time period for preparing an EUA submission for existing COVID-19 serology tests.
- Clinical laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing may continue to use their laboratory developed tests (LDTs) without being required to submit an EUA, provided that they follow previous established guidelines which include validating their test and notifying the FDA of their validation and results.
- While LDTs may not require EUA submission, it is recommended by the FDA.
- Templates for EAU submissions by clinical manufacturers and clinical laboratories are presented in the appendixes of this updated policy.
Commercial manufacturers need to be aware of these new FDA requirements, and clinical laboratories using a commercial COVID-19 serology test kit need to ensure that the manufacturer is following the new FDA guidelines.