The FDA said yesterday it will consider emergency use authorization (EUA) for molecular COVID-19 diagnostic tests to be used solely in the laboratories that developed them.
The laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests. The tests must either be new or represent a significant deviation from an existing commercially distributed EUA-authorized test and not otherwise currently marketed in the U.S.
EUA-eligible tests must also use components either designed and manufactured by the laboratory or represent commercially sourced materials, such as research-use-only (RUO) components from third party manufacturers plus other authorized materials and commonly used ancillary reagents.
The agency said it added this EUA category to increase the number of tests available for COVID-19. It will rescind the authorization when the Department of Health and Human Services declares the public health emergency is over.
More information about applying for the EUA is available here.