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CDRH Extends Response Dates for Marketing Applications

March 24, 2020

To focus on its COVID-19 efforts, CDRH has extended the response dates for premarket notifications, premarket approval applications, Humanitarian Device Exemption applications and De Novo classification requests.

The center is extending the response dates by 60 days for marketing applications on hold as of March 16, 2020, where the response due date is on or before April 30, 2020.

For additional submission types where a response or report is due – such as an Investigational Device Exemption annual report – “we encourage you to submit the response or report when possible,” CDRH said, in a letter to devicemakers.

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