The US Food and Drug Administration (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 FDA collaborate with the medical device industry.
FDA is currently seeking about 100 submitters to participate in the soft launch of the progress tracker for Traditional 510(k) reviews. This limited release will help the FDA refine the usability of the tracker with a smaller audience before it is introduced to all Official Correspondents for all premarket submission types. The submission’s Official Correspondent can use the tracker to securely view the review’s progress in a clear and concise format. The Official Correspondent is the only person who can access this protected information.
Interested submitters can volunteer to participate now.