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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Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.
‘A New Kind Of Future’? FDA’s Shuren Questions Whether Engagement With Industry Will Change Post-Pandemic
US FDA device center director Jeff Shuren is asking whether the agency’s engagement with industry has been changed forever because of COVID-19.
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.