The FDA has issued emergency use authorisation (EUA) for medical tests that diagnose Covid-19, but what is an FDA EUA? To answer this question, let’s first look at the role of the FDA. The FDA is responsible for protecting the public health by ensuring safety, efficacy, and security of all human and veterinary drugs, biological products, and medical devices. With regards to medical tests, the FDA usually does this by making manufacturers meet rigorous guidelines in an approval process that can take many months. During an emergency, such as a pandemic, it may not be possible to have all the evidence that the FDA would usually have before approving a medical test. If there’s evidence that strongly suggests that patients have benefited from a test, the agency can issue an EUA to make it available. One of the minimum requirements for granting EUA is that the known and potential benefits of the test outweigh the known potential risks. However, this is a minimum requirement and not the standard. The minimum standard can be met and EUA is still not given; there may be additional requirements, such as the test meeting reasonable thresholds for safety and effectiveness and/or people in urgent need of care based on a diagnosis. EUAs are only given during a declared emergency; outside of this, an EUA is never given.
This begs the question for manufacturers of Covid-19 tests that currently have FDA EUA: what happens when the pandemic is over? Will authorisation of these Covid-19 tests be revoked? This state of emergency cannot last forever, and eventually, the pandemic will pass. However, Covid-19 testing will still be paramount in monitoring the prevalence of the disease, as well as vaccine efficacy. Once the pandemic is over, Covid-19 testing will likely become a standard similar to influenza testing—just another test in the arsenal for infectious disease diagnosis during the flu and cold season.
DiaSorin Molecular, an in vitro diagnostics manufacturer, recently received federal funding from the Biomedical Advanced Research and Development Authority (BARDA) for its Simplexa Covid-19 direct testing kit, which was given FDA EUA in June 2020. This funding will support the validation and submission of the test for FDA 510(k) clearance, which is one of the normally used medical device regulatory pathways for FDA approval. This means that once the pandemic is over and should FDA EUA of Covid-19 tests be revoked, DiaSorin Molecular will be able to continue marketing its Covid-19 test in the US. GlobalData expects that seeking FDA approval of Covid-19 tests that currently have EUA will better position IVD companies for when the pandemic is over.