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Ann: Lumos Receives US FDA Clearance for FebriDx, page-401

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05/07/23

23:29

Post #: 68643511
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Originally posted by vagabond84: ↑

As I've said before, I'm not an expert in this field and I'm learning through google/bing searches as I go, so I may very well be wrong here.

So I've been reading more about the 510k clearance process. It appears safety and effectiveness are areas the FDA looks at when granting clearance.

"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval."

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

So, my mistake. I was wrong to say the clearance process does not test for safety or effectiveness. I formed this view from statements like this: "The safety of the initial device is not taken into account when another device comes in with a 510k application. They don't have to prove that it's safe and effective, just that it's like another device already on the market." - Former FDA program manager Madris Tomes

(from video in this link: https://www.drugwatch.com/fda/510k-clearance/)

and also this part of the "Drugwatch" blog

"In other words, when the FDA clears a device through 510(k), it is not examining if the product is safe or effective for use in patients. It is just agreeing with the maker’s claim that the device is similar to another device already on the market."
Why the FDA manager would say this, or why drugwatch (which claims its pieces is checked by a qualified medical professional) would make that statement, I don't know. They seemed to be pretty authoritative sources to me.

I think we can all agree though in saying FDA clearance is a lower bar to clear than FDA approval. I still think it's reasonable to call out some posters here claiming LDX has FDA approval and that this is some kind of rare feat that's very difficult to achieve.

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They are both mischievous quotes from people who know better. They are having a whinge about the predicate system which many don't like. It's not as simple as those guys have purported.
FDA clearance is much more strenuous than CE Mark which is why you will see most device manufacturers get their CE Mark approval first. And then worry about FDA.

LDX Price at posting: 8.6¢ Sentiment: None Disclosure: Not Held
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