Progress Tracker for Medical Device Premarket Submissions: FDA Offers Soft Launch
The U.S. 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 us collaborate with the medical device industry.
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.
In January 2021, the FDA intends to have about 100 submitters 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.