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> It's a game-over felony if you're making medical devices. Making medical devices that give fake results usually isn’t even a crime, let alone a felony. Other

> It's a game-over felony if you're making medical devices. Making medical devices that give fake results usually isn’t even a crime, let alone a felony. Otherwise almost all of the makers of home glucose monitors would be in prison. Or walk into your local supermarket and see how accurate the cheapest food thermometers are, if you want an even more basic example.

HeyLaughingBoy 9y ago
There's a substantial difference between a result that is incorrect, but believed to be correct and one that is known to be incorrect, but presented as correct. The former is an error that probably requires the manufacturer to inform the FDA and send out a Customer Letter (a low-level form of product recall). The latter is fraud.
gumby 9y ago
Note: I have previously developed a combo product (device + drug) and have made submissions to and appeared before the FDA on both the pharma and device sides. > Making medical devices that give fake results usually isn’t even a crime, let alone a felony. It very much is a felony and people go to jail. The FDA even can and does make armed (!) raids on facilities when they believe there is fraud. > Otherwise almost all of the makers of home glucose monitors would be in prison. Home glucose monitors in the US only need an accuracy of 20% and the manufacturers have to prove it. And their labeling is regulated just like any other medical product. I don't know why you think that their results are fake. A distal finger stick of capillary blood will not give the same results as a venous draw analyzed with GLP, but nobody is claiming that it should. > Or walk into your local supermarket and see how accurate the cheapest food thermometers are, if you want an even more basic example. These are not regulated products, unless you are using them for commerce (in which case they are regulated by your State, not the FDA).
- Alex3917 9y ago
  > These are not regulated products, unless you are using them for commerce So in other words a major category of medical devices, which are needed to prevent you from dying from eating undercooked poultry or whatever, aren't even regulated, then that seems to support what I was saying.
  - snowwrestler 9y ago
    You absolutely do not need a food thermometer to safely cook food. Time and heat level is sufficient and is how most people (including restaurants, which are regulated) do it.
    - Alex3917 9y ago
      Sure, but if you're relying solely on a food thermometer and it's not giving you accurate results, then it doesn't matter if it's possible to do it some other way. Also it's one thing to not use a food thermometer when making a burger or a piece of salmon, another thing entirely when making a 20lb turkey or whatever.
      - gamblor956 9y ago
        Food thermometers are usually with +/- 2 degrees Farenheit. What sort of food do you cook where a difference of 2 degrees actually matters?
        Alex3917 9y ago
        > Food thermometers are usually with +/- 2 degrees Farenheit. Sure, if you buy any of the top digital thermometers on Amazon. But if you buy a random analog food thermometer at your local dollar store then it's not necessarily going to be much more accurate than a random number generator.
        snowwrestler 9y ago
        I bought a food thermometer in a grocery store; it was obviously off by at least 20 degrees. I just set it aside and cooked as I normally do... I survived the experience. For purposes of this discussion: a food thermometer doesn't work directly on the human body and it is not a medical device regulated by the FDA. (If you are using a food thermometer on a human body, that's still probably not the FDA's jurisdiction--more like local police or the FBI.)

HeyLaughingBoy 9y ago

There's a substantial difference between a result that is incorrect, but believed to be correct and one that is known to be incorrect, but presented as correct. The former is an error that probably requires the manufacturer to inform the FDA and send out a Customer Letter (a low-level form of product recall). The latter is fraud.

gumby 9y ago

Note: I have previously developed a combo product (device + drug) and have made submissions to and appeared before the FDA on both the pharma and device sides. > Making medical devices that give fake results usually isn’t even a crime, let alone a felony. It very much is a felony and people go to jail. The FDA even can and does make armed (!) raids on facilities when they believe there is fraud. > Otherwise almost all of the makers of home glucose monitors would be in prison. Home glucose monitors in the US only need an accuracy of 20% and the manufacturers have to prove it. And their labeling is regulated just like any other medical product. I don't know why you think that their results are fake. A distal finger stick of capillary blood will not give the same results as a venous draw analyzed with GLP, but nobody is claiming that it should. > Or walk into your local supermarket and see how accurate the cheapest food thermometers are, if you want an even more basic example. These are not regulated products, unless you are using them for commerce (in which case they are regulated by your State, not the FDA).

Alex3917 9y ago
> These are not regulated products, unless you are using them for commerce So in other words a major category of medical devices, which are needed to prevent you from dying from eating undercooked poultry or whatever, aren't even regulated, then that seems to support what I was saying.
- snowwrestler 9y ago
  You absolutely do not need a food thermometer to safely cook food. Time and heat level is sufficient and is how most people (including restaurants, which are regulated) do it.
  - Alex3917 9y ago
    Sure, but if you're relying solely on a food thermometer and it's not giving you accurate results, then it doesn't matter if it's possible to do it some other way. Also it's one thing to not use a food thermometer when making a burger or a piece of salmon, another thing entirely when making a 20lb turkey or whatever.
    - gamblor956 9y ago
      Food thermometers are usually with +/- 2 degrees Farenheit. What sort of food do you cook where a difference of 2 degrees actually matters?
      - Alex3917 9y ago
        > Food thermometers are usually with +/- 2 degrees Farenheit. Sure, if you buy any of the top digital thermometers on Amazon. But if you buy a random analog food thermometer at your local dollar store then it's not necessarily going to be much more accurate than a random number generator.
        snowwrestler 9y ago
        I bought a food thermometer in a grocery store; it was obviously off by at least 20 degrees. I just set it aside and cooked as I normally do... I survived the experience. For purposes of this discussion: a food thermometer doesn't work directly on the human body and it is not a medical device regulated by the FDA. (If you are using a food thermometer on a human body, that's still probably not the FDA's jurisdiction--more like local police or the FBI.)