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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Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.
The US agency has announced four more webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.
The US FDA’s list of essential products for use during infectious diseases outbreaks and other public health threats comes almost three months after President Trump signed an executive order directing the agency to develop one.