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.
The FDA is seeking volunteers to participate in a soft launch of the progress tracker for Traditional 510(k) submissions.
On this page:
- Background on the Progress Tracker
- Volunteers for the Soft Launch
- How to Submit a Request to Participate
- Questions about the Progress Tracker or the Soft Launch
The FDA committed to providing a submission tracker in its MDUFA commitments to the medical device industry. (See MDUFA IV Commitments letter, page 11: “an industry dashboard that displays near real-time submission status.”)
The FDA is offering a soft launch of the progress tracker to about 100 submitters, for Traditional 510(k) reviews. This limited release will help the Center for Devices and Radiological Health refine the tracker with a smaller audience before it is introduced to the wider venue of submitters for all premarket review types.
During the 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.
Volunteers will have an ongoing opportunity to provide feedback to the FDA and reach out with any technical support questions. The FDA may contact participants directly to provide feedback about usability of and user experience with the progress tracker.
Dates: The FDA will begin the soft launch during the week of March 8, 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 8, 2021 and May 2021.
Beginning today, interested submitters can submit a request to participate by sending an email to: firstname.lastname@example.org.
The email must include:
- The name, e-mail address, and phone number for the Official Correspondent (as listed in the 510(k), FDA Form 3514 Section C) who will correspond with the FDA about the review of the Traditional 510(k),
- The 510(k) submission number that is under review,
- The firm name and size by number of employees.
The FDA will review requests, notify interested submitters by email and provide information on next steps for soft launch participation. The FDA intends to use a “first come, first serve” approach to review the incoming requests and then identify submitters (that meet stated soft launch requirements) to participate.
Note: The FDA will only review or process requests that are submitted using the process outlined above. The soft launch can accommodate about 100 volunteers with current Traditional 510(k) submissions under review. The FDA may choose to increase the number of participating volunteers during the soft launch period.
If you have questions about the Progress Tracker or the Soft Launch, please send an email to email@example.com.