Monday, March 8, 2021

FDA Seeks Volunteers: Progress Tracker for Medical Device Premarket Submissions

Volunteer today to participate in the soft launch of its 510(k) progress tracker for medical device premarket submissions

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US Food and Drug Administration

FDA Seeks Volunteers: Progress Tracker for Medical Device Premarket Submissions

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 FDA is currently seeking about 100 submitters to participate in the soft launch of the progress tracker for Traditional 510(k) reviews. This limited release will help the FDA refine the usability of the tracker with a smaller audience before it is introduced to all Official Correspondents for all premarket submission types. The submission's Official Correspondent can use the tracker to securely view the review's progress in a clear and concise format. The Official Correspondent is the only person who can access this protected information.

Beginning today, interested submitters can volunteer to participate.

Learn How to Volunteer

Questions about the Progress Tracker?

If you have questions about this Progress Tracker or the soft launch, please email ccp@fda.hhs.gov.


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