The 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 the FDA collaborate with the medical device industry regarding the status of pending premarket device submissions.
Only the submission’s Official Correspondent can use the tracker to securely view the premarket submission review’s progress in a clear and concise format. The Official Correspondent is the only person who can access this protected information.
On this page:
- Background on the Progress Tracker
- Volunteers for the March 2021 Soft Launch
- How to Participate in the March 2021 Soft Launch
- Questions about the Progress Tracker
The FDA committed to providing a submission tracker in its MDUFA commitments to the medical device industry. (See page 11: “an industry dashboard that displays near real-time submission status.”)
In March 2021, the FDA will offer a soft launch of the progress tracker to about 100 submitters, for Traditional 510(k) reviews. This limited release will help the FDA refine the tracker with a smaller audience before it is introduced to the wider venue of submitters for all premarket review types.
During the March 2021 soft launch, the submission’s Official Correspondent will navigate through the progress tracker, which enables them to see the status of their Traditional 510(k) submission. The FDA will ask the submission’s Official Correspondent to provide feedback regarding the usability of the tracker, such as the ease of navigation, utility of the information provided, and tracker functions and features.
Dates: The FDA will begin the soft launch in March 2021 and expects it to run for at least 90 days.
Participant Requirements: Participation is open to submitters with current or upcoming Traditional 510(k) submissions. Specifically, these submitters may participate:
- Submitters with a Traditional 510(k) under review in March 2021
- Submitters planning to submit a Traditional 510(k) between March 2021 and May 2021.
In March 2021, the FDA will update this webpage to announce details on how to submit a request to participate in the soft launch.
Note: The FDA will not review or process requests to participate that are submitted prior to the March 2021 announcement.
If you have questions about the Progress Tracker, send an email to email@example.com.
Please do not send requests to participate in the soft launch of the Progress Tracker at this time. Instructions to sign up will be provided in March 2021.