Division of Clinical Research

Office of the Vice President and Innovation

Category results for: CDER510(k)

Progress Tracker for Medical Device Premarket Submissions: FDA Offers Soft Launch

The U.S. Food and Drug Administration (FDA) is building a secure, web-based tracker that displays the Center for Devices and Radiological Health’s progress on medical device submissions focused on premarket review. The progress tracker is the first feature of a larger platform to help us collaborate with the medical device industry. The submission’s Official Correspondent […]

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