The FDA makes a distinction between approved and authorized tests and devices. During normal conditions and states of affairs, applications for approval on tests and devices are submitted to the FDA for approval. This is a lengthy process that requires many levels of validation, verification, and test trials for both the device manufacturer and/or test provider. This process in general spans anywhere from 18 months to many years. In situations like this COVID-19 pandemic, exceptions are made in the form of “authorizations” the FDA calls them Emergency Use Authorizations (EUAs). The intent of these authorizations is to place new innovative solutions that answer a specific need at the front of the validation line to fast-tracking their approval of use for the period of time deemed the emergency situation exists. Because this is an accelerated process to fill a specific need it is a temporary approval. It means that the FDA has taken the steps to prove its accuracy, viability, and safety in the short amount of time it had to do so. For formal FDA approval, the traditional process is required to provide the time and testing required to determine long-term viability.
Understanding the difference, using saliva to test for viral infection was not something previously tried therefore not an FDA approved testing option. Swabs had been the traditional approved standard. As testing exponentially accelerated supplies became limited and it became clear additional options needed to be discovered. A groundbreaking study done by Rutgers University determined saliva to be 100% equal to swabs for COVID-19 detection and in many cases, it proved to be a better, more sensitive option. This was further validated by an additional study done by Yale University researchers. This delivered EUA approval for Rutger to use saliva for COVID-19 testing based on the very specific and documents protocols they used. This authorization names the SDNA-1000 saliva collection device, manufactured and supplied by Spectrum Solutions, the only sample collection device approved for use. EUA approvals are specific and limited to the processes and procedures outlined in the application for approval. Any deviation from the procedures, devices, or protocols requires additional approval from the FDA.
The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).