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I agree, this law has no effect on APAS, but only because it is...

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Jskl76

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17/12/16

19:02

Post #: 21413039
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Originally posted by imback ↑

This is not related anything APAS has done. The history behind this is the FDA wanted to better identify which software products may be considered medical devices. In theory any software product which displayed, stored or transferred medical data could have been considered anything up to a class 3 device based on previous FDA regs. The FDA tried to clarify this so that those types of software would only be considered Class 1 (low risk), around 5 years ago. However, industry kicked up a fuss and they eventually pushed FDA to declare they are not devices at all, so no regulation to be applied. This law change is the formalisation of that FDA position.

For more background you can look up Medical Device Data systems (MDDS) :

http://www.fda.gov/MedicalDevices/P...Supplies/MedicalDeviceDataSystems/default.htm

So upshot is that it is neutral to LBT. Though it may help them develop little software tools for transferring, storing or displaying test results as they don't need to be developed according to the more stringent FDA documentation needs.

Any software interpreting or diagnosing data has and will always be regulated.

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I agree, this law has no effect on APAS, but only because it is already approved. What I was getting at was the effect it would have on others trying to create and sell the same thing as APAS in the US because, as you said, this formalizes the fact that you need approval to do it.
Just trying to put two and two together, that's all. At first read of the article, I too thought this had nothing to do with APAS, just old news. But after thinking about it, this is what came to mind.

LBT Price at posting: 32.0¢ Sentiment: Buy Disclosure: Held
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