COVID-19 Tests No Longer Need Authorization by FDA for Marketing
In the new announcement, HHS says that COVID-19 tests will no longer require Emergency Use Authorizations (EUAs) prior to marketing. The HHS Notice can be found here.
Citing the principle of “regulatory flexibility” and the Executive Order not to keep ”duplicative regulations and unnecessary policies,” HHS is now saying that FDA cannot require premarket review of laboratory-developed tests (LTDs) – including COVID 19 tests – without notice and comment rulemaking. Thus statements or requirements made in “guidance documents, compliance manuals, website statements, or other informal issuances” cannot be used to require review by the FDA. As a result, “[t]hose opting to use LDTs in their laboratories without FDA premarket review or authorization may do so.”
In plain terms, this means that an EUA is no longer required to market COVID-19 tests. HHS does say that these tests will still be subject to the requirements of CLIA (the Clinical Laboratory Improvement Amendments) and that if an EUA is not obtained, the test would not be eligible for an exemption from liability under the PREP Act (the Public Readiness and Emergency Preparedness Act). EUAs that have been (or will be) authorized by the FDA are exempt from liability under that Act.
Interestingly, the effect of HHS’s “Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests” is not limited to the current pandemic but is in effect for “future pandemics.” This means that LDT and other tests do not require review by the FDA unless there is a specific regulation that has been promulgated under notice and comment rulemaking.