May 9 Meeting with FDA:
In a nut shell, here is how I see the meeting wrapping up in 5 minutes.
Biel: last time, we submitted a 510K to clear Actipatch for knee, foot, back and general muscles and joints. You told us that the real world data that you submitted on back pain was not sufficient and granted us OTC clearance for foot and knee
FDA: That is correct
BIEL: In our recent Pre-Sub, we submitted for your review the clinical trial data on back pain. Also remember that we consulted with you prior to conducting the clinical trial. We believe the data looks solid. What do you think?
FDA: yes it looks good
BIEL: What do we do know. Do you really want us to submit a new 510K or it will be sufficient to supplement the existing one and that’s it.
FDA: Because you already did your homework earlier and this is pretty much exactly like the previous 510K, there is no need to resubmit. A supplement to the existing one should suffice. It normally takes 90 days to make a decision after the submittal of a new 510K. However in this case, it’s a continuation and should take much less longer.
BIEL: Can we get a date?
FDA: within 30 days after receiving your supplemental information
BIEL: Because we have two identical products in the market already, can we start selling back pain and muscle and joint. The device is exactly the same and only the packet is different. We already have packets for back pain and muscle and joints. Take a look.
FDA: In that case we will try our best to provide you with a decision within 15 calendar days after receiving your submittal. You are right, everything looks exactly the same, except the paper packet really.
Adjourn!
ESSENTIALLY, THE DEVICE IS PRECISELY THE SAME AS KNEE AND FOOT
THE PACKAGING IS EXACTLY THE SAME AS KNEE AND FOOT EXCEPT THE PICTURES AND LETTERS
IF FDA accepts the clinical trial data, it should just really move forward rather quickly. Otherwise, it is a pure bureaucracy at best.
Think About It
