QUOTED. 19 April 2021. Jeff Shuren & William Maisel
Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.
“While we’ve never had to take such actions in prior public health emergencies, we've also never experienced a pandemic like this one.” – Jeff Shuren, director, CDRH & William Maisel, director of Office of Production Evaluation and Quality (CDRH)
- Find out more: Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile
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