Electronic 510(k) Submissions Ahead (FINALLY!)

July 12, 2022By Allyson B. Mullen

Last month, FDA announced two important steps towards accepting electronic 510(k) submissions.  The first relates to the Customer Collaborations Portal (or CCP).  As discussed in our prior post on the CCP (here), the CCP is currently a submission tracker providing details of completed and upcoming dates.  At this time, the CCP is only available for Traditional 510(k)s, but FDA has said that it plans to expand the CCP to all submission types in the future.

On June 30, individuals with access to the CCP (i.e., 510(k) correspondents for Traditional 510(k)s since the CCP was originated) received an email from CDRH announcing that “Soon, FDA will let you send new CDRH-led premarket submissions online through our Customer Collaboration Portal (CCP) instead of shipping them as physical media.”  This is welcome news for those of us that have been holding on to CDs and thumb drives to continue to send in submissions.  According to the announcement, the CCP will accept both eSTAR and eCopy submission formats.​  As discussed in an earlier post (here), CDRH piloted the eSTAR electronic submission template last year.  While the tool is useful for ensuring the proper electronic formatting for a 510(k) submission, the output still needed to be downloaded and sent to FDA.

The email also states that the ability to submit completely electronically will first be offered to individuals with CCP accounts so that CDRH can assess the platform’s performance.  Once the initial assessment is complete, CDRH notes that it expects the ability to submit through the CCP will be offered to all premarket applicants.  The announcement does not indicate whether the CCP will allow for submission of all 510(k) types or just Traditional 510(k)s (i.e., the only submission type currently trackable via the CCP).

The announcement concludes by stating that individuals need not do anything to participate because we are already using the CCP, and another communication will come once we are able to begin sending submissions electronically.  Being able to submit completely electronically would be a huge benefit in terms of efficiency and timing for applicants.

The second announcement was made earlier in June through the Federal Register (here), when CBER announced that it would pilot the eSTAR electronic submission template for 510(k)s for biologic products regulated as medical devices. As noted above, the eSTAR electronic submission template was previously piloted in CDRH.  The pilot appears to have gone well now that eSTAR formatted submissions will be accepted through the CCP.  It is a positive next step for eSTAR to be proceeding to CBER 510(k)s.  The pilot will be available to applicants planning to submit Traditional, Special, or Abbreviated 510(k)s.  Interested applicants should contact CBER, at the email in the Federal Register notice.

These two announcements are positive next steps towards standardized electronic submission of 510(k)s for all medical device types.  We look forward to FDA expanding both programs.

Categories: Medical Devices