BioFire COVID-19 Test De Novo Clearance Paves Way For Other EUAs To Stay On The Market
BioFire’s test detects a range of respiratory and bacterial infections, including SARS-CoV-2. Its clearance is the first example of how other products with EUAs can stay on the market after the pandemic.
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The US agency says it’s no longer going to update its list of certain imported respirators that are allowed on the market under an emergency use authorization for health care workers, or accept new applications for the face masks.
Makers of devices and tests granted emergency use authorization by the US FDA are being urged by the agency to not wait until the COVID-19 public health emergency is over to get their products approved – assuming they want to keep them on the market post-pandemic.
The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.