FDA postpones marketing applications, extends response dates due to COVID-19 pandemic

In response to the COVID-19 pandemic, the FDA's Center for Devices and Radiological Health (CDRH) advised the medical device industry that marketing applications are on hold as of March 16, while the response due dates for premarket approvals and premarket 510(k) notifications have been extended.

The centre said it is taking these steps with a view to "[addressing] the impact of the COVID-19 public health emergency on day-to-day operations in CDRH and in the medical device industry, while ensuring that government and private sector efforts to respond to this national emergency receive the highest priority."

The CDRH noted that due dates have been extended by 60 days where the response due date is on or before April 30 for premarket approvals, 510(k) notifications, humanitarian-device exemptions and de novo classification requests.

The centre is also leveraging technology to host teleconferences rather than in-person meetings with industry scheduled through April 30, and added that it continues to receive and process incoming documents. 

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