Cinco de Mayo was a good day–for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention “5″ is my number? 510(k) clearance on 5/5–pretty sweet!
The project has been rewarding and challenging, as with most medical device product development projects.
I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of “refuse to accept” followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA.
Receiving a FDA 510(k) clearance letter is no small feat. Especially in today’s medical device regulatory market. So much more to do, however. I’ll not dwell on this too long.