In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laboratories and commercial manufacturers to accelerate the development of COVID-19 tests. In this guidance document, FDA outlines its policies for the submission of EUA to the FDA for the newly developed test, as well as for the tests that are developed under the authorities of the State and the State takes responsibility of the testing.1
FDA’s Policy for Tests Developed by Laboratories
This newly released guidance allows CLIA certified laboratories to perform specimen testing after the test has cleared validation while the EUA submission is being prepared and submitted to the FDA. This policy is applicable to laboratories that are certified under CLIA and meet the CLIA regulatory requirements to perform high complexity testing. FDA asks laboratories to notify the agency via email of their newly developed test and begin specimen testing if the test has been validated. Laboratories are required to submit EUAs within 15 days of notifying the FDA of their newly developed tests. Failure to do so will result in removal from FDA’s website listing and additional action from the FDA.1
FDA also recommends for laboratories that while their EUA submission is being processed, the first five positive and negative specimens to undergo confirmatory analysis using an EUA authorized assay.
On March 13, 2020, the President issued a “Memorandum on Expanding State-Approved Diagnostic Tests” which allows for States to authorize laboratories to develop and perform tests for COVID-19. In this guidance document, FDA states that it does not intend to object to the use of such tests for specimen testing where the notification validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA. However, FDA does expect that the State authorities that oversee such laboratories to require the development of test methods to validate such tests.1
FDA’s Policy for Tests Developed by Commercial Manufacturers:
FDA does not intend to object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing while their EUA submission is in process or being prepared. However, FDA does require that the tests be appropriately validated, and the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. The manufacturer must also notify FDA via email on the validation and the intent of distribution of the test and must submit an EUA within 15 days.1
Similar to the Laboratories, FDA recommends that manufacturers conduct confirmatory testing on the first five positive and negative specimens using an EUA authorized assay. 1
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1FDA (May 2020) Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) retrieved on 05/19/2020 from https://www.fda.gov/media/135659/download