Monday, August 30, 2021

FDA Launches Progress Tracker for Premarket Submissions

The Progress Tracker displays CDRH's progress on premarket submissions for FDA review.

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FDA - Center for Devices and Radiological Health

The FDA Launches Progress Tracker for Premarket Submissions

Today, the U.S. Food and Drug Administration (FDA) launched a secure, web-based tracker that displays the Center for Devices and Radiological Health's (CDRH) progress on its review of traditional 510(k) submissions. Beginning today, interested submitters of traditional 510(k)s can use the Progress Tracker to view the progress of their submissions.

When you submit a traditional 510(k) submission to the CDRH for review, your Official Correspondent can monitor the FDA's progress online in a simple, concise format. The Progress Tracker is the first feature of a larger platform to help us communicate the progress of a submission in real time with your Official Correspondent.

Only the submission's Official Correspondent can use the tracker to view progress of the review for that premarket submission

Learn More

If you are interested in updates about this feature, subscribe to email alerts.

Questions about the Progress Tracker?

If you have questions about this Progress Tracker, email ccp@fda.hhs.gov.


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