Top CDRH Officials Tell EUA Holders: Don’t Procrastinate In Getting Products FDA-Approved
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.
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Lucira Health executive VP Kelly Brezoczky explains in this Medtech Insight case study how the company shifted gears from making a test for influenza A and B to quickly developing one that detected SARS-CoV-2. The result was the company’s COVID-19 All-In-One Test Kit, an at-home prescription molecular diagnostic test that was the first of its type to hit the market when the US FDA granted it emergency use authorization last November.
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.
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.