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

 
• By Shawn M. Schmitt

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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Two top officials in the US Food and Drug Administration’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.

Center for Devices and Radiological Health director Jeff Shuren and William Maisel, director of the Office of Product Evaluation and Quality within the CDRH, wrote in a joint 15 April...

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