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.”
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‘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.
Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.
The US FDA says the 11 companies were selling masks without agency clearance, approval or authorization. A total of 13 device-related missives were released by the FDA in July.