CDRH is NOW Accepting Electronic Submissions

July 31, 2022By Allyson B. Mullen

On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically.  This came quickly after an announcement was made earlier in the summer that this functionality would soon be enabled for existing users of the CCP (see our prior post here).  As previously noted, this is very exciting news for the device industry, which up to this point has had to continue to ship electronic media to CDRH each time a submission is filed.

One of the key questions we had in our last post was what could be submitted electronically. This was again unclear in CDRH’s most recent announcement so we reached out to the Agency find out more.  CDRH responded that “any CDRH-led premarket submission type can be uploaded including for submissions under review such as responses to RTAs or additional information requests.”  This is very exciting.  As previously noted, the CCP’s functionality for tracking of submissions is, currently, limited to Traditional 510(k)s.  Allowing for the electronic submission of a wide variety of premarket submissions will give CDRH and users greater experience during this evaluation period.

While we’ve not filed any electronic submissions through the CCP yet, based on a first look at the site, it appears it will be a simple upload process.  We are excited to see if it is as simple as it looks, and we will keep readers informed of our experience, if noteworthy.

Categories: Medical Devices