5 ms·

I'm surprised that a 24 person study was considered large enough for the FDA. I've only worked with 'proper' medical devices with much greater potential for har

I'm surprised that a 24 person study was considered large enough for the FDA. I've only worked with 'proper' medical devices with much greater potential for harm, but I'm used to trials involving 100s to 1000s of people.

arkades 9y ago
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.
nonbel 9y ago
Why do you think 24 people is too small a study?
- skywhopper 9y ago
  Presumably because between statistical error and the variability of human biology, a problem that affected a large-ish subpopulation would likely not be detected with such a small study group.
  - nonbel 9y ago
    They always cherry pick who is included in clinical trials and I don't hear the same complaints about that.
    - dragonwriter 9y ago
      You aren't listening, then, because the fact that clinical trials seek people maximally healthy but for the target conditions rather than a representative sample of those with the target condition is a very frequent complaint.
      - nonbel 9y ago
        Where are you seeing this? In every HN thread about some medical trial it is the same complaint about small sample size. It is like a generic complaint thrown by people who don't realize that they are almost all like that...
    - gumby 9y ago
      The agency has to approve your selection criteria and those criteria affect what you can write on your label (i.e. who the drug can be used for). Good example: the Gardasil vaccine is only approved for those under 27 as it was only tested in that age range.
- mikeash 9y ago
  If the device has a 1% chance of eating the user’s brain, that’s probably unacceptably high, but such a study would be unlikely to discover it.

arkades 9y ago

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.

nonbel 9y ago

Why do you think 24 people is too small a study?

skywhopper 9y ago
Presumably because between statistical error and the variability of human biology, a problem that affected a large-ish subpopulation would likely not be detected with such a small study group.
- nonbel 9y ago
  They always cherry pick who is included in clinical trials and I don't hear the same complaints about that.
  - dragonwriter 9y ago
    You aren't listening, then, because the fact that clinical trials seek people maximally healthy but for the target conditions rather than a representative sample of those with the target condition is a very frequent complaint.
    - nonbel 9y ago
      Where are you seeing this? In every HN thread about some medical trial it is the same complaint about small sample size. It is like a generic complaint thrown by people who don't realize that they are almost all like that...
  - gumby 9y ago
    The agency has to approve your selection criteria and those criteria affect what you can write on your label (i.e. who the drug can be used for). Good example: the Gardasil vaccine is only approved for those under 27 as it was only tested in that age range.
mikeash 9y ago
If the device has a 1% chance of eating the user’s brain, that’s probably unacceptably high, but such a study would be unlikely to discover it.