I agree FDA as a whole has other issues well ahead of this one on its priority list. As for whether FDA is likely to "challenge" it, I'm not clear on what type of challenge you might see in the course of counseling on devices.
I don't know too many device companies that would seek legal counsel if the issue was cited as a deficiency during IDE review. Perhaps if the FDA declined to approve the IDE on the basis of this issue, which strikes me as unlikely, except under circumstances where it probably should be rejected.
The scenario in which I think a device company would be most likely to seek legal counsel is if the FDA decided to put an ongoing IDE study on investigational hold. If that's what you are referring to, this strikes me as unlikely, except, again, under circumstances where it probably should be put on hold. That's because I think that, once the IDE is approved, the use of an IDE as cover for commercialization would have to be pretty blatant for it to come to FDA's attention.
I guess another scenario in which a device company might seek legal counsel would be if the FDA declined to accept the data from an IDE study upon determining it had been used as a cover for commercialization. How likely this might be, I can't even begin to guess.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 15-Apr-2017 07:43
From: Mark DuVal
Subject: Sale of investigational devices
Folks this whole discussion is on a topic which is really not large on FDA's radar screen because a) of the difficulty in actually dtermining the recoupment cost, FDA is not equipped to challenge that (but you say its never stopped them before��); and b) the actual cost of recoupment at the stage of a non-commercialized device is higher than a company could charge the market. With reimbursement challenges standing in the way of most investigational and cleared/approved devices anyway, this is just not a focus of FDA's review. My advice, just be reasonable and don't worry about it. Of the many hundreds of devices we've counseled on in 35 years, I've never seen this challenged. It used to be debated a lot more in the 80s and into the early 90s, but FDA has much bigger fish to fry today.
Mark DuVal, J.D., FRAPS
DuVal & Associates, P.A.
Sent from my Verizon, Samsung Galaxy smartphone