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Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile

Executive Summary

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.

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