A Review of CDRH’s Electronic Submission Process

September 14, 2022By Allyson B. Mullen

As promised in our posts from earlier this summer (here and here), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP).  In short, the process is FANTASTIC!  Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier.  FDA’s CCP allows for a simple drag and drop to upload of a zip file containing your full eCopy directly to the Center.  The site, alternatively, allows for uploading of an eSTAR formatted submission.  The upload process really couldn’t be easier.  The instructions are simple and the site is user friendly and intuitive.

This author has now submitted two 510(k)s using the system.  It has been seamless.  In both cases, the 510(k)s were submitted in the afternoon/early evening.  We immediately received an automated confirmation through the website after each was submitted.  Then, the following business day, we received the confirmation email from the Document Control Center identifying the submission number.

The CCP also tracks your sent submissions as well as your Traditional 510(k)s currently under review.  In our view, this submission functionality is a great technological step forward for CDRH.  We look forward to the application being opened up to allow additional users to submit electronically and for the tracking function to be expanded to other submission types (e.g., pre-submissions, IDEs, Special 510(k)s).

Categories: Medical Devices