The FDA 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 you submit a traditional 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.”)
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 510(k) submissions, the most common submission type.
- 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 [email protected].