The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.
If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.
Because the FDA DOES have jurisdiction over medical testing devices. They approve all of those pee-on-a-strip tests for pregnancy/ovulation. They have jurisdiction over home glucose test machines and home blood pressure machines. This is written into their charter. Part of why they exist is to prevent dangerous or at the least ineffective patent medicines and health machines.So… Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.
The FDA is not demanding the system be pulled, they are asking the manufacturer to explain why this is not the same as the devices they already have jurisdiction over and have to approve.Biosense Technologies Private Ltd.'s uChek system isn't cleared by the Food and Drug Administration and the agency said it wants to know why not,
So Is this device food? Or is it a drug? I was under the impression that it was something that you peon. Maybe I am mistaken. I can't see why the FDA thinks they would have any jurisdiction over that.
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.
If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
*I think I used the app wrong... *wipes urine off iPhone*
how do you know the app's results are real without any testing or verification?
This is front page worthy? Seriously?
Aye. Personally I don't trust auto-WB for my own family photos, let alone medical results.
Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
It's the fed, so "for free" still means they'll grossly overpay their incompetent selves with our money.This only makes any sense if the FDA undertake to test submitted apps for free since if you dont you limit the creation of apps to ..... wait for it.....
drug companies who can afford it
Or not. It could be that they want to make sure he app is doing its job correctly. Imagine if it gave a wrong result and someone ended up in the hospital. Or dead.
You want to make sure you're in the correct kind of light, and that the camera properly white balances before you accept the photo for analysis, that's for sure!
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.
If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
You don't need a cameraphone to read a urine dipstick, you only need a pair of eyeballs. Unless you're colorblind or just plain blind, I guess.
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.
If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Q: Why did Captain Kirk pee on his iPhone?
A: To go where no man has gone before.
Laugh. It's Friday.![]()