FDA Provides Progress Tracker System for Premarket Submissions

August 30, 2021—FDA advised that it has built a secure, web-based tracker that displays the Center for Devices and Radiological Health’s (CDRH) progress in reviewing traditional 510(k) submissions. When a traditional 510(k) submission is submitted to CDRH for review, the applicant’s Official Correspondent can monitor the FDA’s progress online in a simple, concise format.

According to the announcement, the FDA offers online progress tracking to fulfill its Medical Device User Fee Act (MDUFA) commitments. (Page 11 of the MDUFA IV Commitments letter includes a commitment to “an industry dashboard that displays near real-time submission status.”)

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

The FDA announcement also noted the following:

• If this is an Official Correspondent’s first time tracking a submission online, the FDA automatically emails them a link to create a log-in password soon after the FDA starts its review. The sign-in function is here.
• The FDA currently displays progress online for traditional 510(k) submissions, which is the most common submission type.
• The FDA formally notifies the Official Correspondent of the submission’s status by emailing them with official actions and requests.
• Questions about how the FDA informs submitters of their premarket submission’s progress should be addressed via email to ccp@fda.hhs.gov.