Due to the emergent nature surrounding the development of COVID-19 tests, the processes for FDA-authorization are different. During a public health emergency, the FDA utilizes different authorizations and tests in order to meet the urgent need for products:
Emergency Use Authorization (EUA):
For applicable emergencies, the FDA can issue a EUA to allow for more timely access to essential medical products when there are no other approved options available. This EUA process is not the same thing as full approval, but the FDA does evaluate the options using whatever evidence is available, weighing the pros and cons before extending the EUA.
Lab Developed Test (LDT):
An LDT test is a laboratory diagnostic test that is manufactured by and used within a single laboratory. Under the Clinical Laboratory Improvement Amendments, the FDA is able to provide flexibility to labs that develop and perform their own testing. These tests are validated and sent to the FDA with the corresponding data.
State Authorization:
The FDA is providing flexibility to states who want to authorize labs certified to conduct high-complexity tests in that state to develop and perform coronavirus testing. Under this policy, the state or territory takes responsibility for the safety and accuracy of COVID-19 testing by laboratories in its state/territory and the lab does not submit a EUA request to the FDA.