FDA Start Online 510K-Review Tracker
(Thursday, September 2, 2021)
Starting this Monday, 30 August 2021, submitters of traditional 510(k) applications can directly track the progress of the review of their applications on FDA’s website via an online web-based tracker. This should allow applicants to plan their subsequent steps in marketing their product under review. The most common complaint from submitters of any application to the FDA is the lack of transparency of the review status of a given application within FDA. Although FDA has established statutory timelines for application reviews, FDA does not send out any intermediate notifications on the status of an application’s review. Reaching out to reviewers or project managers asking for status is futile, first because they are not required by their process to provide such updates, and second, they are usually very busy to find time to respond to such queries. Internally though, FDA has a streamlined process to track workload of its reviewers and application review status. These internal trackers are used by FDA’s project managers and management for tracking applications. Now, it seems FDA will provide a glimpse of these internal trackers to outside parties, only for traditional 510(k) applications, to the applicants. To protect confidentiality of the applicants and applications, this status tracker will only be accessible to the official correspondent for a given 510(k) application and is not a public display of status. Starting this week, FDA would automatically email links to create a login password for the 510(k) tracker to the official correspondents of traditional 510(k) applications, after which the official correspondent can login to track their application status online. It seems that the process is only available to future applications and not retrospective to applications filed prior to this week. If you have a traditional 510(k) application with the FDA, you can email email@example.com, for your access link to the 510(k) tracker. FDA would still send letters for official actions and requests to the official correspondents, as before. This first-of-a-kind tracker by FDA could and should, in future, be expanded to other applications as well.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC