CDRH is currently running a pilot program to accept 510(k) premarket notification submissions packaged using the eSubmitter tool (see my previous post). The purpose of the pilot is to collect information to assess the value of the template in facilitating review and approval of eligible submissions. The main differences between the pilot and the regular 510(k) submission process are:
Only limited types of traditional and abbreviated 510(k)s are eligible. They must have a primary product code on the list of 39 codes pre-selected for the pilot, not be a combination product, and have their lead center as CDRH. The pilot does not include special 510(k)s, in vitro diagnostics, or biological products.
The submission must be constructed using the eSubmitter template “CDRH: Non-In Vitro Diagnostic Device – 510(k)”. The recommended content for the submission has not changed – the tool ensures all of the information is present before creating the package for submission. The electronic file created by the tool must be copied to CD and mailed to the CDRH Document Control Center along with the hard copy cover letter and applicable user fees. The ESG will not be used; Patrick Axtell of the FDA noted during the pilot program webinar that they learned from the 2014 pilot that “folks don’t like the ESG”.
The review process will not have a “refuse to accept” review, because the template and tool won’t create a submission that is missing information, so this review will be waived. The review process will occur through email and phone and will be more interactive, so sponsors should be prepared to respond promptly to their reviewer. The FDA expects to make a final decision on the submission by FDA day 60 following receipt, which is faster than the standard 90-day review date.
I attended the webinar, and the Q&A session contained a few additional clarifying details, including the expected length of the pilot (at least 3-6 months, with notification in advance of the pilot end date), whether additional products would be added to the primary list (not during the pilot, however the center will accept suggestions on codes to add for potential future use), and other details about the review process (hold to request additional information still available, and amendments cannot be submitted using eSubmitter). The slides, audio recording, and transcript are available at the webinar site. If your submission is eligible, I encourage you to give the program a try.
Text and Image Copyright © 2018 Katrina Rogers