HP&M’s Review of New CDRH Submission Tracker

December 1, 2021By Allyson B. Mullen

Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions.  The platform is called the Customer Collaboration Portal (CCP) and is “a secure, web-based tracker that displays the CDRH progress in reviewing traditional 510(k) submissions.”  See announcement here.  The CCP is currently only available for Traditional 510(k)s.

Now that sponsors have had the opportunity to use the system for a couple of months, we thought we would share our thoughts on it.  Unsurprisingly, we think it’s great.  It includes all the necessary information for each submission under review including the reviewer and all relevant dates in a concise format.  A sample is shown below.

This summary also appears to remain available even once a final decision is made on the 510(k).  To date, completed 510(k) submissions are still showing in the CCP.  This historical reference may also be useful to sponsors in the future.

While sponsors have always had all of these dates, they have had to keep track of them manually and then calculate when the next interaction will/should occur.  It is, certainly, convenient to have it all in one place.  Also, at the top of the page, there is a helpful tracking bar that shows how long until the next major date; for example, when the sponsor’s response to a hold letter is due or when FDA expects to render its decision on the 510(k).  Examples of the tracking bar are shown below.

Again, sponsors could always calculate these dates but having a location where they are easily accessible is expedient and ensures that there is a clear and consistent understanding between the sponsor and the Center.  We applaud the Center’s efforts to make this system available.  Sponsors who have not previously used the system will automatically be sent login credentials shortly after CDRH begins its review of the submission.

In terms of improvements – the system provides all the basic information for Traditional 510(k)s.  Given that this is only one type of submission that sponsors will file, it would be helpful to have all submission types included in the CCP going forward.  Also, in the future, it would also be nice if copies of the relevant correspondence to the sponsor were also linked to in the submission for ease of reference.  But, for now, in our view, the CCP is a welcomed tool for sponsors.

Categories: Medical Devices