Background
As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, “eliminating the need for a hard copy or a compact disk.”
The hope, FDA said, is that the program will be able to increase adherence and compliance with its various regulatory requirements and recommendations. The “guided interface,” which FDA officials have compared to the tax preparation software TurboTax, will have several features to “ensure appropriate regulatory submission standards and recommendations are met or considered,” FDA said in a Federal Register notice announcing the program.
The net benefit to both FDA and industry should be more compliant 510(k) submissions and less time-consuming application submissions and reviews.
Expanding List of Participants
For now, the pilot program only accepts unbundled, traditional 510(k) submissions for classified devices –not third party 510(k)s or applications for combination products, FDA said.
But according to Nels Anderson, a biomedical engineer within FDA’s Vascular Surgery Device branch, the program is now expanding and looking for new participants. While the pilot had started off focused on just a handful of cardiovascular device types, the pilot is now expanding to include all cardiovascular devices regulated by CDRH’s Office of Device Evaluation (ODE), Anderson said.
Eight companies have already reportedly enrolled in the program, and Anderson characterized the companies’ interactions with it as “positive” and being “much faster” than the traditional applications process. Making amendments to an application, in particular, is much quicker and easier, he added, allowing for same-day submissions and cutting down on delays caused by FDA waiting for an application.
Future Goals: All Application Types
And while the pilot program was built with smaller companies in mind, Anderson said CDRH’s intent is to eventually expand the program to include all types of device submissions, starting with all 510(k)s before eventually including Premarket Approval (PMA) applications as well. That endpoint is still “years down the road,” Anderson said. For now, FDA is looking to engage with more small device companies with cardiovascular product lines, and is hoping to receive between 50 and 100 submissions to fully test the capabilities of the eSubmissions Program. Anderson said companies wishing to participate in the expanded program can e-mail FDA or find more information on FDA’s website.
REFERENCE: RAPS; 25 AUG 2014; Alexander Gaffney, RAC