ARTICLE SUMMARY:
Starting next October, every 510(k) sent to FDA will have to be compiled with CDRH’s eSTAR electronic template and submitted via its new online portal. Here’s a look at this big shift from the device center’s analog past and some expert tips on making the transition.
FDA’s device center is known as a relatively innovative section of the agency in many respects, but it has been a backwater in one particular area: the means by which companies can compile and transmit premarket submissions.
Electronic templates and submission portals have been well-established for drug and biologic applications, but as recently as three years ago, device companies were still shipping massive piles of paper submissions along with an “eCopy” of the application on a CD or thumb drive to FDA headquarters. The paper requirement was finally removed in 2019, but mailing physical electronic media containing files that FDA staffers have to manually download and then map to internal review templates has remained the standard practice.
But that’s finally changing. Progress toward a more digital CDRH future has accelerated in the past few years as a result of big IT investments by the center (which were somewhat controversial during the latest user fee negotiations with industry) and serious work on standardizing the structure of submissions. Those efforts have resulted into two new foundational platforms: 1) the CDRH Customer Collaboration Portal (CCP), which for the first time allows sponsors to forgo FedEx and send submissions directly online; and 2) the electronic Submission Template and Resource (eSTAR), an interactive PDF-based submissions form that (at least for 510(k)s and De Novos, so far) directly mirrors CDRH’s SMART template, which reviewers follow internally.
On October 3, the center opened up CCP for anyone submitting any type of premarket submission and pre-submissions. And starting next October, eSTAR submissions via CCP will be required for 510(k)s, with mandates for other submission categories coming down the pike.
“One of my cautions is that people are going to think, ‘Oh, this is going to walk me through it. I can just do it even though I have no experience.’”
The general online-ness of it all has been a long time coming. It’s hard to find anybody who wants to keep placing CDs addressed to Silver Spring, MD, in the mail. “Moving CDRH into the 21st century where we don’t have to be mailing things is such a huge improvement,” says Jared Seehafer, CEO of Enzyme, a QMS/submissions platform and consulting company, which participated in FDA pilots of both CCP and eSTAR.
But the transition to a new submissions template in eSTAR, while clearly a move in the direction of efficiency, is not trivial. It comes with many of the potential hiccups and investments linked to any big IT upgrade and requires companies to reframe how they make a clear case for their device in an FDA submission.
