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FDA Will Regulate Some Apps As Medical Devices
chicksdaddy writes "In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, 'when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"
So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?
That's what this is about. The FDA neither has the time nor energy to look at every stupid 'medical' app in the store. They're only going to deal with ones that have an interaction to hardware that can cause problems or if the app is really, egregariously touting some medical benefit that it can't possibly provide.
Faster! Faster! Faster would be better!
So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?
Why the fuck would you use a mobile app to control an IV pump? That's like running a production database for a fortune 500 company off of Arch Linux.
You don't use something that isn't stable to run something as important and life critical as an IV pump. Nor would any hospital do so and any individual that tried would simply be a victim of natural selection.
You know what else they don't have in Somalia?
1. Patent trolls.
2. DMCA.
3. Central Government Spying.
So if you are in any way against any of those things then you want America to be exactly like Somalia. Thank you for playing the deluded Straw Man game!
AntiFA: An abbreviation for Anti First Amendment.
Why the fuck would you use a mobile app to control an IV pump?
The point is really two-fold. First, we already regulate medical devices like infusion pumps and radiology information systems. Under the proposed regime, one does not simply avoid regulatory scrutiny and obligations by offloading them to an app.
Second, if a app makes claims to do things things that would ordinarily be regulated, you don't escape the regulatory regime simply by saying, I'm just an iPhone app.
Both prongs make some sense if you accept the basic assumption that FDA regulation of devices makes sense at all.