First, ask yourself why the submission was rejected. Was it because of the RTA? If so, that’s an easy fix and, usually, although you lose a few weeks or even a month or two, it’s not the end of the world.
It becomes much more interesting when you get a submission kicked back or rejected because of scientific review. First and foremost, you want to work directly with your reviewers to address their concerns. Maybe you are not sufficiently explaining what it is that you're doing and why.
For example, you can often bolster your case by including letters from subject matter experts (SMEs), perhaps to better explain why the statistical methodology you used makes sense. I use SME letters frequently because it doesn’t cost much time or money. I make it very clear to the experts that I do not want them to laud my device; I simply want them to verify that my method is generally accepted in the statistical community for this particular application.
If, despite all reasonable efforts to address the issue, you remain at an impasse with the reviewers, you have the option to take your case to the Ombudsman’s office. The Ombudsman is not part of CDRH; they report directly to the office of the commissioner, acting as an independent arbitrator.
You (the manufacturer) present your case to the Ombudsman, the reviewers present their case, and the Ombudsman will make a determination as to who is right. The reason I only advise this course of action as a last resort is because it can lead to you winning the battle (i.e., the Ombudsman’s office makes a determination in your favor), but losing the war — you may encounter those reviewers again in the future, and they may be none too thrilled to see you again.
I would like to say that doesn’t happen in the real world, but I also didn’t fall off the turnip truck yesterday; people are only human. Bottom line, the Ombudsman pathway is a legitimate pathway. Manufacturers have the right to use it. Just use it as a last resort.
Conclusions
If a submission is kicked back because of scientific review, then that is the FDA is doing its job exactly as it’s supposed to. Perhaps there was an honest disagreement in terms of how you analyzed your data, statistical methods you used, or the design of your test methodology, and that’s fair game.
But, if a submission is kicked back on administrative review — in other words, because of the RTA guidance — then, quite frankly, that’s the company’s fault. Be thorough in completing your RTA checklist for any regulatory submission, use the proper forms, and conduct a “beta test” before sending everything off to FDA.
