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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The head of the US agency’s device center tells Medtech Insight that while he’s proud of his staff for taking on the extra workload due to the pandemic, product review times are slowing because resources are stretched thin.
US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt – to the COVID-19 pandemic when it comes to medical device and diagnostic regulation.
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.