CCP Improvements Allow Industry to Track Pre-submissions

June 5, 2023By Allyson B. Mullen

FDA recently released further updates to the Customer Collaboration Portal (“CCP”).  Readers of the blog will know that I am a HUGE fan of the CCP (see our earlier posts here and here).  It has made filing of all premarket submissions much easier by facilitating a direct upload of the submission to FDA.

The CCP has also allowed industry the ability to track the status of 510(k) submissions.  The CCP identifies the 510(k) date of receipt, and the number of days until a decision/response is due.  It also lists all major 510(k) submission milestones and when they are complete.

The most recent updates to the CCP allow sponsors of Pre-submissions to track their status just as they are able to do for 510(k)s.  Just like the 510(k) tracker, the pre‑submission tracker shows the official correspondent the date on which the submission was received and the major milestones.  As shown in the screenshot below, the milestones include (i) acceptance decision, (ii) setting the meeting date, (iii) providing written feedback, and (iv) holding the meeting.  Sometimes pre-submissions do not follow as predictable a path as 510(k)s.  By providing standard pre-submission timelines, we hope it will provide greater transparency to sponsors as to the status of their pre‑submission review.

We look forward to continuing to see the expansion of the CCP.

Categories: Medical Devices