The Food and Drug Administration (FDA) issued revised guidance regarding the policies for COVID-19 testing during the public health emergency (PHE). The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests, including two policies for accelerating the development of certain laboratory tests; a policy for commercial manufacturers to more rapidly distribute tests to laboratories for specimen testing; and a policy regarding the use of serological testing.
Generally, the policies are modified to employ stricter thresholds for validation and clarify that Emergency Use Authorization (EUA) requests should be made within 15 days of diagnostic tests being distributed and within 10 days of serological tests being distributed. Validation study recommendations can be found on p. 17 through 20.
The highlights of each policy within the final guidance follow:
- Development of laboratory tests that leads to EUA submission – This policy applies to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) that develop diagnostic tests and pursue an EUA. The FDA notes that this policy remains unchanged from the initial publication on February 29, but some process updates and clarifications have been made. The final guidance details requirements related to validation criteria, reporting of validation results, and the submission of an EUA request within 15 days of the test being distributed.
- Development of laboratory tests under the authorities of the State – This policy allows states to validate and authorize diagnostic tests developed in clinical labs within the state. The FDA clarifies that this policy remains unchanged from the second publication of this guidance on March 16.
- Commercial distribution of diagnostic testing to laboratories – This policy applies to commercial manufacturers that seek to develop and distribute diagnostic test kits to clinical labs or to healthcare workers for point-of-care testing. The FDA notes that this policy remains unchanged from the second publication of this guidance on March 16, but some process updates and clarifications have been made. The final guidance clarifies that an EUA request should be made within 15 days of distributing the diagnostic tests, and provides recommendations regarding the validation of tests.
- Serological tests – This policy applies to developers of serology tests that identify antibodies to COVID-19. The FDA revised this policy on May 4 to employ stricter validation criteria and clarify that an EUA request must be made within 10 days of the serology test being distributed. Additionally, the guidance provides recommendations for labeling and reporting serology test results.