The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system to help companies track the progress of the agency’s review of their 510(k) submissions.
The FDA’s Premarket Submission’s Progress Tracker currently allows a medical device manufacturer to access up-to-date information on the status of traditional 510(k) submissions, which represent the most common type of device applications submitted to the FDA for review. Access to the Progress Tracker is limited to the “Official Correspondent” identified in the original submission, who will automatically receive an email with instructions on accessing the Tracker once the FDA has started its review of the submission.
Read more information about the FDA’s Premarket Submission’s Progress Tracker.
