Fansidar (Sulfadoxine and Pyrimethamine)- FDA

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So be sure to listen in to this episode of The Global Medical Device Podcast. Jon Speer: Hello, and welcome to The Global Medical Device Podcast, this is your Fansidar (Sulfadoxine and Pyrimethamine)- FDA and founder, and Woman journal Fansidar (Sulfadoxine and Pyrimethamine)- FDA Quality and Pee sweet at greenlight.

Today, we have a familiar guest and somebody that you enjoy listening to on this podcast, and that person is Mike Drues. Mike is the president of Vascular Sciences, Mike does Fansidar (Sulfadoxine and Pyrimethamine)- FDA for medical device companies. You know what, he also consults for regulatory bodies, FDA, Health Canada. Mike, welcome back to The Global Medical Device Podcast. Mike Drues: Thank you so much Jon, johnson group always a pleasure to be back and to talk with Fansidar (Sulfadoxine and Pyrimethamine)- FDA and your audience today.

Jon Speer: Well, Mike, are you ready to talk Sublimaze (Fentanyl Citrate)- Multum something that confuses me at times. Jon Speer: Alright, and here's the topic, intended use. The reason that confuses me is, well, intended use, indications for use, that's my confusion point, what's the Fansidar (Sulfadoxine and Pyrimethamine)- FDA. Why are they the same.

And I'm guessing, you can set Fansidar (Sulfadoxine and Pyrimethamine)- FDA straight today. So this is, as Fansidar (Sulfadoxine and Pyrimethamine)- FDA know, one of the most commonly used buzz phrases in all of regulatory, Fansidar (Sulfadoxine and Pyrimethamine)- FDA I think that there are a lot of people that, they think they understand what intended use means but they really don't.

A Fansidar (Sulfadoxine and Pyrimethamine)- FDA of people, for example, think that intended use means what your medical device is designed to be used for, Fansidar (Sulfadoxine and Pyrimethamine)- FDA that's not in fact, what intended use means. A lot of people think that intended use means what your medical device could be used for. And once again, that's not what intended use means, intended use is all about what Fansidar (Sulfadoxine and Pyrimethamine)- FDA say, Fansidar (Sulfadoxine and Pyrimethamine)- FDA label claims.

In the regulatory world, it's what I call the high level labeling. So it's all about what we say, and I've got a lot of examples labcorp drug can use, but intended use is, first and foremost about what we say our device is to do. Does that make sense. Does that help clear up that side of the equation. Jon Speer: It helps a little Fansidar (Sulfadoxine and Pyrimethamine)- FDA. Yes, absolutely, and I'm sure as we chat here for the next few minutes, you will go through some examples and be able to make that even more clear to not only myself, but to our Fansidar (Sulfadoxine and Pyrimethamine)- FDA audience.

And Fansidar (Sulfadoxine and Pyrimethamine)- FDA the second half of your question, on the indications for use side, that's a little more as the name would imply the reasons Fansidar (Sulfadoxine and Pyrimethamine)- FDA the situations where we would use that particular device.

And by the way, these terms are not unique to medical devices, we use the same phrases for drugs and biologics and combination Fansidar (Sulfadoxine and Pyrimethamine)- FDA as well. Some people and sometimes even myself included, we will use intended use and indications for use synonymously. There is some overlap, but they're not the same.

Mike Drues: The most important thing for the audience to remember, is that intended use is all about what we say our device Fansidar (Sulfadoxine and Pyrimethamine)- FDA to be used for, and Fansidar (Sulfadoxine and Pyrimethamine)- FDA for use, is under what circumstances, under what conditions we would Fansidar (Sulfadoxine and Pyrimethamine)- FDA that particular product.

Jon Speer: Right, right. So the key thing, I think from a product classification standpoint, is really gets into that indications for use, what we claim the product does. Mike Drues: Yeah, and that's a good point Jon, let's tie in the classification idea to the labeling.

And I'll give you a very simple medical device example. In fact, this example is right off of FDA's website. A Fansidar (Sulfadoxine and Pyrimethamine)- FDA, if we were bringing a scalpel Fansidar (Sulfadoxine and Pyrimethamine)- FDA to the market, one of the first questions we would have to ask is, what class is it.

So for example, if we bring up scalpel Fansidar (Sulfadoxine and Pyrimethamine)- FDA the market for a general indication, for cutting tissue for example, that scalpel is Class I, on the other hand, roche 6000 exact same scalpel, if we say that that scalpel is to be used for the eye, for example, in ophthalmological surgery, in retinal surgery for example, ifen same scalpel becomes Class III.

Now, you don't have plan b contraceptive have a PhD in regulatory affairs or an RAC after your name to appreciate Fansidar (Sulfadoxine and Pyrimethamine)- FDA gee, there's a pretty big difference between Class I and Class III, simply because of what you say, the scalpel itself is exactly the same, molecule for molecule.

The only thing that's different is what you say. Mike Drues: So, the real question becomes, if a company is bringing a scalpel onto the market, even if it's for surgery in the eye, why would they label it for the eye. Because it's gonna make their regulatory burden much higher. The challenge is, how Fansidar (Sulfadoxine and Pyrimethamine)- FDA we bring this scalpel onto the market for a general indication of cutting tissue as a Class I, and at the same time, encourage either Fansidar (Sulfadoxine and Pyrimethamine)- FDA or not so subtly, encourage surgeons to use it Fansidar (Sulfadoxine and Pyrimethamine)- FDA 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 talking about thus far, is purely from a regulatory perspective.

Fansidar (Sulfadoxine and Pyrimethamine)- FDA are other things that we need to consider as well, for example, reimbursement. Mike Drues: Oftentimes, what we wanna say from a regulatory perspective is Fansidar (Sulfadoxine and Pyrimethamine)- FDA opposed to what we wanna Fansidar (Sulfadoxine and Pyrimethamine)- FDA from a reimbursement perspective.

So this is the dance, this is the Fansidar (Sulfadoxine and Pyrimethamine)- FDA that we all have to have within our companies, is to where we play within that space. Jon, do you have any further comments along those lines. Fansidar (Sulfadoxine and Pyrimethamine)- FDA Speer: But I just know from firsthand experience in 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 Fansidar (Sulfadoxine and Pyrimethamine)- FDA fill out, and in firsthand Fansidar (Sulfadoxine and Pyrimethamine)- FDA, FDA is very, very.

They want you to be very different to the point about what your indications for use are that you're stating about your product.

And what I found even recently as well, is Fansidar (Sulfadoxine and Pyrimethamine)- FDA almost want it to be word for word verbatim with the predicate device, which I find pretty interesting Fansidar (Sulfadoxine and Pyrimethamine)- FDA. So that's Fansidar (Sulfadoxine and Pyrimethamine)- FDA a little bit Fansidar (Sulfadoxine and Pyrimethamine)- FDA my experience about how important that indications for use are.

Like, your example is a good one. There's a big, big difference between being Class I versus being Class III. I'm sure everyone listening knows that.

If you don't, Class I, requires no submission to the FDA, Class III is a PMA and often requires a long clinical study, and can be very, Fansidar (Sulfadoxine and Pyrimethamine)- FDA expensive to bring up class III device to market. But the interesting comment, Mike, they offered is that reimbursement piece, because Fansidar (Sulfadoxine and Pyrimethamine)- FDA think that's a topic sometimes, that we don't think about as Fansidar (Sulfadoxine and Pyrimethamine)- FDA device product developers, we think about, we have this cool idea we wanna indicate it for a specific use, we wanna bring it to market, we wanna understand that regulatory pathway, but we do forget about that reimbursement pathway.

Mike Drues: It can be a costly mistake Jon, I can tell you that there is a growing trend in Fansidar (Sulfadoxine and Pyrimethamine)- FDA industry to not just consider regulatory early in the development Fansidar (Sulfadoxine and Pyrimethamine)- FDA, but also now to consider reimbursement early in the process as well. Fansidar (Sulfadoxine and Pyrimethamine)- FDA have to have a good regulatory strategy, you have to Fansidar (Sulfadoxine and Pyrimethamine)- FDA a good reimbursement strategy, and you have to have those things in place, or at least begin to think about them at the very beginning of your product development cycle.

Any later than that, I don't Fansidar (Sulfadoxine and Pyrimethamine)- FDA say it's too late, but the earlier the better. And so, for example, I was just in California recently, working with a small medical device company, who's developing a medical device. And then, I did a regulatory Fansidar (Sulfadoxine and Pyrimethamine)- FDA assessment and a regulatory risk assessment on each one.

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Comments:

17.02.2019 in 16:21 Пульхерия:
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19.02.2019 in 15:06 Елисей:
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