4 ms·

They submitted via 510(k), a loophole abused by many manufacturers these days. They didn’t have to show this device was safe, just that it’s “substantively simi

They submitted via 510(k), a loophole abused by many manufacturers these days. They didn’t have to show this device was safe, just that it’s “substantively similar” to an existing device. The bar for evidence is low-to-laughable.

cryptonector 9y ago
Is it somehow inappropriate in this case though? Please explain.
ska 9y ago
That's not correct. You always do safety and efficacy analysis, but with a 501(k) you don't have to stage clinical trials as you would with a PMA. The bar is certainly lower than a PMA, but it isn't laughable. This is a difficult trade off. If everything went through a PMA as currently defined, we would have a tiny fraction of the devices that we do today, and they would cost orders of magnitude more. The FDA is trying to balance access to beneficial technology with risk, and it isn't an easy line to draw.
castleanthrax 9y ago
Created an account because I am a medical device engineer. You're mischaracterizing 510ks quite a bit. A 510k states that a new device has the same medical indication as a previous device, and you don't have to demonstrate efficacy via clinical trials. In this case the medical indication would be "corrects vision." The darkening is a new feature that is not likely a medical indication. Regarding safety: You absolutely have to show safety. Any new material, additive, or processing chemical used for an existing indication must be demonstrated to be safe. This also applies if a currently used material is used in larger quantity, or used in a more serious degree of contact (longer duration, more invasive). This is done through biocompatibility testing in accordance with ISO 10993.
iancmceachern 9y ago
Another medical device design engineer here and I second the previous comments that this comment is 100% incorrect. 510k isn't a loophole, shortcut or less safe in any way. Clinical trials are unbelievably expensive, hundreds of millions of dollars or more. Often so much so that they are prohibitively expensive for alternatives to therapies that already exist or for patient populations that aren't large enough to make back the initial investment. Without the 510k pathway much of our modern medical treatment portfolio wouldnt exist as drugs and devices for only the very most lucrative health problems would be cash positive to develop. Thanks to 510k devices thousands of lives are saved every day, and therapies that were once too expensive for the masses can now be afforded.

cryptonector 9y ago

Is it somehow inappropriate in this case though? Please explain.

ska 9y ago

That's not correct. You always do safety and efficacy analysis, but with a 501(k) you don't have to stage clinical trials as you would with a PMA. The bar is certainly lower than a PMA, but it isn't laughable. This is a difficult trade off. If everything went through a PMA as currently defined, we would have a tiny fraction of the devices that we do today, and they would cost orders of magnitude more. The FDA is trying to balance access to beneficial technology with risk, and it isn't an easy line to draw.

castleanthrax 9y ago

Created an account because I am a medical device engineer. You're mischaracterizing 510ks quite a bit. A 510k states that a new device has the same medical indication as a previous device, and you don't have to demonstrate efficacy via clinical trials. In this case the medical indication would be "corrects vision." The darkening is a new feature that is not likely a medical indication. Regarding safety: You absolutely have to show safety. Any new material, additive, or processing chemical used for an existing indication must be demonstrated to be safe. This also applies if a currently used material is used in larger quantity, or used in a more serious degree of contact (longer duration, more invasive). This is done through biocompatibility testing in accordance with ISO 10993.

iancmceachern 9y ago

Another medical device design engineer here and I second the previous comments that this comment is 100% incorrect. 510k isn't a loophole, shortcut or less safe in any way. Clinical trials are unbelievably expensive, hundreds of millions of dollars or more. Often so much so that they are prohibitively expensive for alternatives to therapies that already exist or for patient populations that aren't large enough to make back the initial investment. Without the 510k pathway much of our modern medical treatment portfolio wouldnt exist as drugs and devices for only the very most lucrative health problems would be cash positive to develop. Thanks to 510k devices thousands of lives are saved every day, and therapies that were once too expensive for the masses can now be afforded.