“During the past several months we have been working diligently and methodically to ensure that we enter the FDA pre-submission meeting in the strongest possible position and with the highest probability of securing near-term clearance,” Dr. Aklog explained. “First, we formally engaged the founding partner of one of nation’s leading FDA law firms to advise us through this process. We then prepared a pre-submission package which carefully codified the large amount of testing data and other documentation generated during the review of the original application, in a manner and structure easily digestible by newly-assigned FDA personnel.”
PAVmed submitted this comprehensive package last month. A pre-submission meeting with the FDA has been scheduled for January 7, 2019. The lead branch for this resubmission remains unchanged but the FDA has assigned a new, more senior, lead reviewer. He will work closely with the lead branch reviewer and chief who participated in the review of the initial application.
“We are excited to have secured a pre-submission meeting with the FDA and eagerly anticipate the opportunity to make our case that CarpX is substantially equivalent to the predicate device and should be granted 510(k) marketing clearance,” Dr. Aklog said. “We anticipate that, as requested, specified senior FDA personnel empowered to make executive decisions on our application will be present at the meeting. PAVmed management will be joined at the meeting by a world-class team, including our FDA counsel and recognized experts in carpal tunnel surgery who strongly support CarpX’s substantial equivalence arguments.
“We continue to advance towards several other important CarpX milestones,” Dr. Aklog added. Next week we expect to secure Ethics Committee approval which should allow us to perform our first-in-human CarpX clinical series in New Zealand in December. The ISO 13485 certification process and quality management system setup required for CE Mark submission in 2019 are both well underway. We also continue our efforts to establish a commercial infrastructure through active discussions with distributors in the U.S. and abroad.”
