Unfortunately, even because you fail to see it, it does not mean that it's not there.
Please, by all means, enlighten me!... That's why I started this thread. But please also note that just saying "it's there" is not very convincing if you don't make a clear and specific argument to support that statement.
I'm glad we agree that this is not an instance of enforcement discretion. One less thing to look into.
In fact, as I mentioned, it's easy to see directly from the regulation, but as I mentioned, you probably need the right frame of mind (and when I talking about "frame of mind"I'm talking about the frame of mind of the reader, not from the FDA, because for them the text has always been clear).
How can it be "
easy to see directly" if "
the right frame of mind" is necessary?... What IS the
right frame of mind? I always thought that the regulation should be (and is) accessible to people with uni-level English, average or better intelligence and several years of experience in successfully implementing these and similar regulations (all of which I consider myself to have).
I'm sure that this section is clear to the FDA. That's not the point. The point is understanding how the wording of the regulation leads to the FDA's practice (if need be, with the assistance of official FDA guidance or other FDA written explanations).
Besides from that, as I mentioned before, this text is 40 years old, and has not been changed, so implying that it's wrong or being treated wrongly does not seem like a good conclusion. What I usually think in these cases is, probably someone has been under these circumstances and had to get a solution, so usually the fact is that, although I myself cannot see the solution to the problem, the solution must exist somewhere (and I probably am not aware at the moment where it is).
I didn't intend to imply that the regulation is wrong or has been treated wrongly. I only wrote that
to me it doesn't make sense at the moment, and I asked help in
improving my own understanding. My conclusion was just as you described: "
I myself cannot see the solution to the problem, the solution must exist somewhere." However, I don't usually suffice with someone saying to me "
Rest assured, the solution is out there, somewhere!...", unless they point to where exactly it is and, preferably, also explain beyond doubt the connection, applicability, and rationale behind their argument. Of course, no one (including you) is obliged to meet that expectation, but unless they do I tend to stay sceptical. I hope you can excuse me for that. My motivation is to gain such a level of understanding that I am, in turn, able to explain it to someone else, beyond reasonable doubts I may encounter. I don't usually answer questions with "someone once told me that it's okay, though I'm not 100% sure why, so you should believe that too!" I want to be able to convince my audience with facts and solid arguments.
Ah! Now this may be helpful. Thank you. I will have a look and come back if I find something interesting.
I didn't, at any point, intend to imply that this is something new, so the answer's age (any good answer) is not important IMO. I'm simply looking for a solid answer.
both situations you mentioned clearly do not apply on the given scenario of 807.81 (a) (1), so there's no requirement for a premarket notification.
807.81(a)
(1) is irrelevant, because I was arguing that the last scenario I described falls under 807.81(a)
(2). If that is the case (and at this stage you haven't explained why it's not; I'm actually not sure you are actually saying it's not, because you keep coming back to (a)(1)), then clause (a) [the paragraph before (1), (2) & (3)] applies, and it says that a premarket notification IS required. Item (2) would trigger it independent of item (1) [
"any of the following"].