4 ms·

> What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, wh

> What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed. I don't think anyone in this chain has tried to claim that the 510(k) is not a safety process nor that it is not followed - merely that avoiding more rigorous testing and review of a new device by tying it to the safety rating of a previous device sounds exactly like what happened with boeing's 737 max, and secondly, that existing regulations incentivize bad outcomes whereby companies make more expensive/dangerous/worse products that get less testing. > What do you think the substantively equivalent bar for a 510(k) allows a company to do? Honestly, I have literally no idea, and have been trying to tease that information out of you. Specifically, how does that bar differ from the one that Boeing had to clear with the 737 Max took which took 5 years and a few billion dollars (I don't know how much of that was for compliance, but we can guess its at least 10s of millions). This is literally the first article I found when I searched google: https://www.medicaldesignandoutsourcing.com/boeings-737-max-crisis-why-the-medical-device-industry-should-care https://www.medicaldesignandoutsourcing.com/boeings-737-max-...

ska 6y ago
> and have been trying to tease that information out of you I really didn't get that from your comments. I will try. 1st off I'm no expert in aerospace regulation or anything like it so perfectly happy to be wrong, but my assumption is this: The 737max issue arose because of a combination of two things. 1 the engineering standards at Boeing have been eroded (so they cut corners) and 2) the FAA has been subject to regulatory capture to the degree that they did not catch this (or did not/could not act effectively when they did). If I'm wrong here please advise. Now I suspect there are a lot of differences in how broadly these things are applied so I will try and draw as close a parallel as I can. Imagine you and I have a med dev company and we are building a new version of a device X, call it X2, and we are using a self-predicated 510(k) to do it. When we file that we still have a full system V&V. We have a hazard analysis that can included everything for X, but must focus on any functional differences between X and X2, We run all our system trace & testing, produce he documentation, and file it with the FDA panel. Now if the panel don't like anything in the V&V (or the rest of the filing) they can ask use to support it better, and that includes the previously covered aspects. If they think the predicate is too much of a stretch they can kick it back. If we can't make them comfortable they can push it to refile with new methods or a to a full PMA (i.e. clinical trials) and force us to go the whole route (along with anyone else doing the same thing, they can't just target our company). We absolutely can propose pretty much anything to address the variations in our machine, but they don't have to accept any of them. So I can see how we might pressure our engineers to cut corners, and we can see how we might paper it over to file. But I can't see the mechanism where the FDA fails to do it's part (or for that matter, how a clinical trial would have caught everything that might be missed that way). Make sense? Again, I'm not saying the FDA couldn't have such a problem, all regulatory bodies can. I just don't see evidence that it does have this problem. And the narrative that the creation of a 510(k) path was due to regulatory capture seems pretty weak, for what it's worth.

ska 6y ago

> and have been trying to tease that information out of you I really didn't get that from your comments. I will try. 1st off I'm no expert in aerospace regulation or anything like it so perfectly happy to be wrong, but my assumption is this: The 737max issue arose because of a combination of two things. 1 the engineering standards at Boeing have been eroded (so they cut corners) and 2) the FAA has been subject to regulatory capture to the degree that they did not catch this (or did not/could not act effectively when they did). If I'm wrong here please advise. Now I suspect there are a lot of differences in how broadly these things are applied so I will try and draw as close a parallel as I can. Imagine you and I have a med dev company and we are building a new version of a device X, call it X2, and we are using a self-predicated 510(k) to do it. When we file that we still have a full system V&V. We have a hazard analysis that can included everything for X, but must focus on any functional differences between X and X2, We run all our system trace & testing, produce he documentation, and file it with the FDA panel. Now if the panel don't like anything in the V&V (or the rest of the filing) they can ask use to support it better, and that includes the previously covered aspects. If they think the predicate is too much of a stretch they can kick it back. If we can't make them comfortable they can push it to refile with new methods or a to a full PMA (i.e. clinical trials) and force us to go the whole route (along with anyone else doing the same thing, they can't just target our company). We absolutely can propose pretty much anything to address the variations in our machine, but they don't have to accept any of them. So I can see how we might pressure our engineers to cut corners, and we can see how we might paper it over to file. But I can't see the mechanism where the FDA fails to do it's part (or for that matter, how a clinical trial would have caught everything that might be missed that way). Make sense? Again, I'm not saying the FDA couldn't have such a problem, all regulatory bodies can. I just don't see evidence that it does have this problem. And the narrative that the creation of a 510(k) path was due to regulatory capture seems pretty weak, for what it's worth.