EUAs Pose Single Largest Health Technology Risk, Safety Group Says
The organization ECRI cited emergency use authorized products as the biggest risk in a new report, saying the temporary clearances aren’t built to ensure lasting safety.
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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.
The US agency says there are now at least 6,400 NIOSH-approved respirators or configurations that can sufficiently meet the domestic supply needs of health care workers.
IVDs: ‘Every Non-COVID Premarket Submission That Was Held Up Is Moving Forward’ Soon, FDA’s Shuren Vows
Jeff Shuren, director of the US FDA’s device center, promised in a podcast interview with AdvaMed that the agency’s backlog of in vitro diagnostic submissions not related to COVID-19 will begin abating “in the next few weeks.”