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  1. Industry (Medical Devices)

Tracking Your Premarket Submission’s Progress (Progress Tracker)

The FDA built a secure, web-based tracker that displays the Center for Devices and Radiological Health’s (CDRH) progress in reviewing Traditional, Abbreviated, and Special  510(k) submissions. When you submit a 510(k) submission to CDRH for review, your Official Correspondent can monitor the FDA’s progress online in a simple, concise format.

The FDA offers online progress tracking to fulfill its Medical Device User Fee Act (MDUFA) commitments. (See MDUFA IV Commitments letter, page 11: “an industry dashboard that displays near real-time submission status.”)

Track Your Submission

The FDA secures the information about each submission’s progress so only its Official Correspondent can view it.

  • If this is your Official Correspondent’s first time tracking a submission online, the FDA automatically emails them a link to create a login password soon after the FDA starts its review.
  • The FDA currently displays progress online for Traditional, Abbreviated, and Special 510(k) submissions.
  • The FDA formally notifies you of your submission’s status by emailing your Official Correspondent with official actions and requests.
  • If you have questions about how the FDA informs you of your premarket submission’s progress, email ccp@fda.hhs.gov.

CDRH Premarket Online

Updates for the medical device industry on CDRH’s efforts to make more premarket activities available online.

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