COVID-19

How Coronavirus Tests May Be Authorized

Americans rely on the FDA to provide an independent review of medical products, such as drugs, diagnostic tests, and other medical devices. During a public health emergency like the COVID-19 pandemic, there is an urgent need for products to diagnose, treat, or prevent a medical threat. There are three ways a coronavirus test might be used for this emergency:

Emergency Use Authorization (EUA) In certain types of emergencies, the FDA can issue an Emergency Use Authorization, or EUA, to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available options. The EUA process is different than full approval or clearance because in some emergency situations we cannot wait for all of the evidence needed for full FDA approval or clearance. Instead, the FDA evaluates the options very quickly using the evidence that is available, carefully balancing the risks and benefits of the product as we know them, in addition to evaluating other criteria.Lab Developed Test (LDT)A laboratory-developed test (LDT) is an in vitro (or laboratory) diagnostic test that is manufactured by and used within a single laboratory. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The FDA is providing flexibility to certain labs certified under CLIA to run high-complexity tests during the COVID-19 emergency. The FDA is providing flexibility for labs that develop and perform their own coronavirus testing where the lab validates the test, notifies FDA, and submits the validation data to the FDA within a certain timeframe as part of a EUA request. While many labs purchased commercial tests under an existing EUA, other labs developed and validated their own tests under this temporary policy.State AuthorizationThe 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.

This information has been provided by the  FDA

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