Sponsors May Now Request Access to the CCP for Filing of Device Premarket Submissions Electronically

It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP).  We heard from a number of readers after our prior post (here) asking how they could get access to the CCP.  Up until now, access was limited to pilot users who had been granted access during the last year.  On October 3, 2022, CDRH announced the expansion of this program.  Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically.  CDRH’s website provides a link to request access to the CCP (here).  We are certain this will be welcome news for those of you who were not part of the pilot program.

There also appears to be another exciting expansion to the CCP—the ability to track all types of 510(k) submissions.  As discussed in our prior post (here), the CCP has allowed, since its inception, the ability for pilot users to track Traditional 510(k) submissions only.  According to CDRH’s website, “When you send a CDRH 510(k) submission (traditional, special, and abbreviated 510(k)s) for review, your official correspondent can monitor the FDA’s progress online in a simple, concise format.”  The tracking feature is useful to sponsors during the review process to ensure alignment with the Center on timelines and review status, and it will only grow in its utility now that all 510(k) types can be tracked.

We hope others are as excited about the CCP as we are!