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Testing Basics

Diagnostic Approval Process During the COVID-19 Pandemic

The US Food and Drug Administration (FDA) is responsible for approving new medical devices, including diagnostics, for use. Emergency use authorizations (EUAs), issued by the FDA, allow for an accelerated, conditional authorization for use of a medical countermeasure or device during a public health emergency to help detect and combat a new disease that poses a significant threat. First established in 2007, the EUA process allows for manufacturers to market new devices on an accelerated timeline.

EUAs have been extensively used during the COVID-19 pandemic, and any COVID-19 diagnostic test or serology test available for public use should have an EUA.

FDA EUAs are not FDA approvals. While an EUA can allow a manufacturer to market a test and an individual or healthcare provider to use a test, an FDA EUA is not equivalent to an FDA approval. An EUA, granted after review of a test, provides temporary, emergency use of a test. Each type of COVID-19 test must meet a specific set of requirements to qualify for an EUA. These thresholds are quality controls. While the test may not have full FDA approval, manufacturers must provide data that the test performs well and they must provide sufficient information on protocols, testing platforms, and other relevant details to the FDA. Any test that does not have an EUA has not had the manufacturer provide this information to the FDA or had any independent review of the test.

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How is a FDA EUA different from an FDA approval?

Although FDA EUAs are granted faster than the normal FDA approval process, they are conditional and time bound.

To get an EUA, the following requirements must be fulfilled:

  1. The Secretary of the US Department of Health and Human Services declares a public health emergency
  2. The public health emergency must be a serious, life-threatening illness
  3. The device in question “may be effective” in diagnosing, preventing, or treating the disease
  4. Known benefits of use outweigh the known risks
  5. There currently are no alternatives to this device, test, or medical countermeasure

The EUA is valid only while there is a public health emergency and these conditions are met, it can be revoked or terminated at any time.

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