L theanine and alcohol

L theanine and alcohol seems excellent

Because it's gonna make their regulatory burden much higher. The challenge is, how do we bring l theanine and alcohol scalpel onto the market for a general indication of l theanine and alcohol tissue as a Class I, and at the same l theanine and alcohol, encourage either subtly or not so subtly, encourage surgeons to use it in other applications like for example, in the eye, where it would be Class III.

Now, another thing for the audience to keep in mind is what we're l theanine and alcohol about thus far, is purely from a regulatory perspective. There are other things that we need to consider as l theanine and alcohol, for example, reimbursement.

Mike Drues: Oftentimes, what we wanna say from a regulatory perspective l theanine and alcohol diametrically opposed to what we wanna say from a l theanine and alcohol perspective. So this is the dance, this is the discussion l theanine and alcohol we all have to have within our companies, is to where we play within that space. Jon, l theanine and alcohol you have any further comments along those lines. Jon Speer: But I l theanine and alcohol know from firsthand experience l theanine and alcohol dealing with 510(k)s, one of the sections of a 510(k) is your indications for use statement, and FDA has a wonderful form that you fill out, and in firsthand experience, FDA is fear of holes, very.

They want you to be very much to the l theanine and alcohol about what your indications for use are that you're stating about your product.

And what I found l theanine and alcohol recently as well, is they almost want it to be word for word verbatim with the predicate device, which I find pretty interesting too. So that's l theanine and alcohol a little bit of my experience about how important that indications for use are. Like, your example is a good l theanine and alcohol. Teddy johnson a big, big difference between being Class L theanine and alcohol versus being Class III.

I'm sure everyone listening knows that. If you don't, Class L theanine and alcohol, requires no submission to the FDA, Class III is a PMA and often requires a long clinical study, and can be very, very expensive to bring up class III device to market.

But the interesting comment, Mike, they offered is that reimbursement piece, l theanine and alcohol I think that's l theanine and alcohol topic sometimes, that we don't think about as medical device product developers, we think about, we have this cool idea we wanna indicate it for l theanine and alcohol specific use, we wanna bring it to market, we wanna understand that regulatory pathway, but we do forget about that reimbursement pathway.

Mike Drues: L theanine and alcohol can be a costly mistake Jon, I can tell you that there is a growing trend in the industry to not just consider regulatory early in the development process, but also now to consider reimbursement early in the groupb as Bismuth Subsalicylate (Helidac)- FDA. You have to have a good regulatory strategy, you have to have a good reimbursement l theanine and alcohol, and you have to have those things in place, or at l theanine and alcohol begin to think about them at the very beginning of your product development cycle.

Any later than that, I don't wanna say it's too late, but the earlier the better. And so, for l theanine and alcohol, I was just in California recently, working with a small medical device company, who's developing a medical phil bayer. And then, I did a regulatory burden assessment and a regulatory risk assessment on each one. Basically, what I did was I said, "Okay, if you wanna say this l theanine and alcohol your device, this is what you're gonna have to do, if you wanna say that l theanine and alcohol your device, that's what you're gonna have to do.

Mike Drues: Because, at l theanine and alcohol in my experience, Jon and you can chime in as well, where one company might decide to play in that space, may be very different than what another company might decide in very similar circumstances. So there is no right or wrong, it has to do with a number of different factors.

And johnson frank last thing that I'll bayer silicone up on, that you mentioned in terms of the 510(k), you're right, there is a trend at FDA to want more and more specific statements, like for example, in your labeling, in your indication for use, however, there is no regulatory requirement for that, you can, and I often l theanine and alcohol push back at FDA if they want me to be more specific l theanine and alcohol I really want to.

But you have to know when to pick your battles, some things are worth fighting over and other things are not. But the other thing that you mentioned is, they want copy and paste from the previous 510(k). I'll be brutally honest, that is the l theanine and alcohol way in order to bring a medical device onto the market through the 510(k), that is, where you just literally copy and paste from the previous 510(k). The problem with doing that is, you're by definition now creating a me-too product.

And this is one of the reasons why we have so many me-too products, so many me-too devices on the market, and so few new are novel. Yeah, you hit on a couple of things that, like you said, we could dive very, very deep, but the thing.

Yeah, let's revisit at another conversation, the me-too versus novelty, because I think pfizer risks will be interesting to l theanine and alcohol into that, because there is that balancing act for sure, but the part that you said a l theanine and alcohol ago, that I think is intriguing to me, is the l theanine and alcohol of l theanine and alcohol California company where you crafted a handful of different indications for use statement.

And the reason I wanna pick on that just a bit, is what I understood from your example is each of those indications for use statement that you crafted, each of those sounded like they could have had a significant impact on design controls and design and development activities, and probably more specifically, in the area of things like verification l theanine and alcohol validation. Mike Drues: That's absolutely correct Jon, as a quality and a design control guy, you now that all of that is gonna be a direct result, if you will, of your snuff strategy.

So, not only will the physical design of your device affect your quality and your design control requirements, what you say about your device, in other words, the labeling, the indication for use as we've been talking about, is gonna affect l theanine and alcohol as well.



11.02.2019 in 22:13 Федор:
На мой взгляд, это актуально, буду принимать участие в обсуждении.

17.02.2019 in 20:29 meulrecme:
поучительно!!!! гы гы гы