Diagnostic tests for COVID-19 during the public health emergency are covered by FDA guidance issued in March 2020. To accelerate availability of such tests, FDA created a fast-track system that FDA 510k Consultants guides its clients through. An outline of the process for commercial development and distribution of tests follows below.
Note that FDA’s guidance applies to diagnostic test kits intended for use by clinical laboratories or by healthcare workers for point-of-care testing. It does not apply to at-home testing.
Also note that FDA allows distribution of a validated test before preparation of an Emergency User Authorization (EUA) submission. The Agency expects the manufacturer or distributor to deliver that submission within 15 business days after distribution begins.
The Pathway Forward
- Step 1 – Validation. The clinical test should be validated prior to use. Validation testing depends on the nature of the test:
- molecular diagnostics (detection of coronavirus nucleic acids),
- antigen detection diagnostics (detection of coronavirus antigens), or
- serological diagnostics (detection of antibodies to coronavirus).
- Step 2 – FDA Notification. Following completion of validation, FDA should be notified the assay has been validated and distribution is intended to begin.
- Step 3 – Test Reports Before EUA Acceptance. FDA wants test reports to include a general statement that the test has been validated but FDA’s independent review of this validation is pending.
- Step 4 – EUA Request. FDA 510k Consultants prepares and submits a formal request for EUA authorization of the diagnostic test.
- Step 5 – Website Disclosure. While awaiting FDA determination, the manufacturer or distributor should make publicly available on its website the instructions for use, including a summary of assay performance.
Special disclosures are required in test reports based on serology tests that identify antibodies (such as IgM, IgG) to SARS-CoV-2.
How We Can Help
FDA 510k Consultants prepares the EUA submission and guide its clients through regulatory compliance. As soon as an engagement letter is executed, we provide an EUA Checklist of information required to prepare the submission. Once the data is received, it takes a few days to assemble and submit the EUA to FDA. We remain your advocate until FDA finalizes its review.