FDA Will Regulate Some Apps As Medical Devices 130
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.'"
Re:Woohoo! (Score:5, Funny)
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!
Re:Woohoo! (Score:5, Insightful)
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.
Re:Woohoo! (Score:5, Insightful)
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.
Re:Woohoo! (Score:4, Insightful)
Why would you put a poorly-tested embedded bluetooth stack in a pacemaker that crashes under fuzzing? Crazy, right?
If it's anything like it was when I was in medical software, the FDA is more concerned with process than specifics of implementation. If you're practicing good software development and QA methodologies and you can impress your ISO9001 auditor, then the FDA won't be too tough. Then again, "those were the days", so maybe somebody can update this - last time I flew to FDA for a development seminar was the first time I got wanded by TSA.
Re:Woohoo! (Score:4, Insightful)
These days they have ISO 13485 [wikipedia.org]. It's a lot like ISO 9001, but drops the more marketing continual improvement and customer feedback and adds additional requirement for creation of requirements, something more-or-less non existent in 9001.
So theoretically, 13485 would require you to recognize risks (e.g. fuzzing) and add mitigation (e.g. not crashing) to your requirements, which would then be tested and all the in a similar matter to 9001. I'd say that as a result it's about as good as can really be expected. The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.
For completeness it's worth mentioning that when it comes to diagnostic software (I believe this started in the last couple years) they also require clinical trials to verify effectiveness somewhat like they do for medicine. Therefore if you write an application that, say, helps determine if someone is concussed (the case which started diagnostic software, IIRC) then you actually have to collect data for concussed and non-concussed people (verified by traditional means) and prove that it can provide a meaningful diagnosis.
Re: (Score:2)
The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.
Yes, in many cases the only 'experts' are the people who wrote the code. All you can really do is minimise risks by erecting procedural walls and testers between the experts, the accountants, and the patients. Sure it slows things down, bumps up costs, and is still not 'failsafe'. But that's the price of working under the motto "first do no harm".
Aside from that, in most western nations if your software does kill or injure someone, your 'principle engineer' better be able to demonstrate due diligence s
Re: (Score:3)
A wide variety of medical devices currently use Windows (often XP) to provide the client interface. Most Doctors have smart phones, so getting the buggy, unreliable, insecure Windows box out of the picture may appeal to some ... and leveraging the technology that the staff already have is not unreasonable (yes, there's some OTHER computer actually monitoring the flow. But setting the rates? Receiving alerts? ... why not use the smartphone?).
As to whether the FDA does a good or bad job (or a bit of both), it
Re: (Score:2)
A wide variety of medical devices currently use Windows (often XP) to provide the client interface.
I hope that the Feds on Drugs Administration has thoroughly tested those Windows as well. I can't imagine a medical device having anything COTS-related that wouldn't be isolated in some safe way that would make testing the front-end at least less important, if not completely meaningless. You don't prevent Therac-25-like incidents by vetting an XP client that controls everything, you prevent them by minimizing the implementation into a single-purpose controller with bulletproof interface to the XP client. Li
Re: (Score:2)
Re: (Score:3)
It's well known that principles are expensive. The majority of the $6k for the device and software represents
Re:Woohoo! (Score:5, Insightful)
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.
Key Point (Score:2)
you don't escape the regulatory regime
Exactly. Ever. And that is the root of the problem.
Re: (Score:2)
The FDA came about this because there were a HUGE number of apps that did medical quackery.
Yes, quackery, as in back to the snake oil days. You may recall many apps claimed to do stuff like cure acne and analyze your skin for stuff like melanoma and things like that.
The problem was the first claimed to do it by "exposing the acne to a special light", which ended up just being a specific color of the screen. And there wa
Re: (Score:3)
Oh get off. The stated goal of the agency (to prevent companies and individuals selling products which are patently unsafe, causing harm to consumers, or making medical claims which are patently false) is a necessary one, otherwise scumbags would be (taking it to the extreme) selling cyanide pills and claiming they cure cancer.
Whether the agency is living up the goal they claim, or acting in a corrupt fashion is another story entirely.
Re: (Score:2)
My god you're delusional. If you give "the market" free reign to do as you say, "the market" will create a rating agency that panders to the needs of the industry while pretending to cater to the needs of the customers. Yes, letting advertisers regulate themselves worked well. Worked great for content ratings too. Oh wait, no it doesn't.
And I'm sure we'd all love to live in Andrew Ryan's Rapture.
Thankfully, society doesn't agree with you.
Re: (Score:3)
No, I'm not wrong. People aren't wrong just because they disagree with you. That is an example of a lack of integrity, and probably explains why all your accounts have a starting score of -1. Because even if you were right (and frankly I believe you are not) you come across as a dick.
Re: (Score:2)
Well, yes. But the side effects are a bit shit.
Re: (Score:2)
I run Arch on my desktop and laptops and it requires *orders of magnitude* less maintenance than the Mandriva system it replaced...not that that's saying much. Of course Mandriva still beat Ubuntu -- I could never manage to get an Ubuntu system fully working in the first place! (granted, the last time I tried was probably six years ago when it was a fairly new distro...)
Re:Woohoo! (Score:4, Insightful)
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.
From your mouth to God's Ears.
But just in case someone was thinking of doing this the FDA is going to step in and set guidelines.
Why: Because people are re-purposing cellphones for all sorts of stuff, most of it not well thought out.
You can find examples which contain unvetted information on the Google Play store. Some of this might find its way into actual use in the field, because in all too many cases doctors and computers live in two different worlds, and may come to trust something that looks approximately right, only to find out its horribly wrong in some places:
Examples (with no allegations of incorrectness or danger, simply to show examples that already exist):
https://play.google.com/store/apps/details?id=com.shahlab.anesthesiologist [google.com]
https://play.google.com/store/apps/details?id=net.klier.blutdruck [google.com]
https://play.google.com/store/apps/details?id=com.qxmd.calculate [google.com]
https://play.google.com/store/apps/details?id=com.mobisystems.msdict.embedded.wireless.mcgrawhill.ivdh [google.com]
https://play.google.com/store/apps/details?id=com.sekos.dosagecalc [google.com]
So yeah you might thing such doesn't exist, and these might be harmess infomation apps, but who's to know when nobody is watching.
And with NFC built into every phone these days, who's to say someone won't find another use for it?
which is quite the point. why use rhino horn? (Score:2)
That's exactly when the FDA should step in, and when they have, historically. It doesn't make any sense to try to cure diabetes with lizard tails. If you sell lizard tails as a diabetes cure, the FDA may come knocking. If you sell a magnet hat as brain cancer protection, the FDA may want to talk to you. If you sell a strobe light app as a cure for emphysema, same thing.
Really this is just another case of "on a computer doesn't change anything". If you sell a "cure" for a disease, the FDA may want to hav
Re: (Score:2)
I agree that the software should be stable and tested (and that is the purpose of these regulations).
As to "why use a mobile app to control an IV pump"... let me count the ways.
Use your imagination.
- patient is in isolation... don't touch the pump
- nurse can monitor and control a lot of pumps from one application
- the application can check for problems with the pump
- the application can check for drug interactions
- the application can check for drug overdoses
- the application can check lab values and recom
Re: (Score:2)
How about the following?
1. An app that interfaces with a glucose reader that calculates what dose of insulin and when to administer but miscalculates and over/under prescribes.
2. An app that displays ECGs for cardiologists but mis-displays and life threatening illnesses are missed.
3. A portable ECG that mis-records? I used to work at a company that uses puck sized ECGs with USB interfaces.
4. An app that interfaces with a blood pressure cuff and attempts to diagnose high blood pressure.
A smart phone makes a
Re: (Score:2)
By your logic we should never do anything because it is not safe.
The world is moving on and us kids will happily get off your lawn and take our new mobile shinies with us. We are moving into a world where the data gets shot through the air and my device fits in my pocket. You can bitch about it or you can help us make it work. The IV pump you mention CAN accept its inputs from mobile apps. But between the app and the IV pump should be something that is going to validate the inputs coming from the app.
Re: (Score:2)
You're young and apparently stupid. There is a name for people like you, "Organ donors"
Re: (Score:1)
What would probably happen is the actual logic and safeties would be written in an embedded board on the IV pump, and then the app would be a remote display app, with a touchscreen interface allowing you to adjust settings within predefined limits.
I used to work in medical imaging, and people floated the idea of display apps on iPads for doctors to view images, but the display quality wasn't good enough for medical diagnosis. Even our monitors on our equipment had a disclaimer that they weren't for medical
Re:Woohoo! (Score:4, Interesting)
Speaking as a Diabetic- yes I do.
I wear an infusion pump already. And a continuous monitor. They're plastic screens and buttons I clip to my belt. They have to be easily accessible because there is so much variance day-to-day.
Having everything talk via ANT or BT or something. Having one controller for it all. It'd be wonderful. I think your point is that it's too dangerous to put all that burden on a single piece of commodity hardware. And that's a valid point, in theory. But in reality, if I can replace the pump UI and CGM UI with a phone **that I'm already carrying** I end up with a whole lot fewer widgets to keep track of. Also, by virtue of commoditization, I could replace the software stack infinitely easier than a purpose-built controller, Dangerous? Sure. But understand the position we're in now:
I don't care if it's dangerous or voids the warranty or puts the FDA boogey-man on me. If a development like this occurs in the future and the FDA impedes it, I would like the opportunity to get it. Running on an open stack, even a quasi-open stack, is the only viable way for that to happen. And for today, smartphones are the best way to make that happen.
Re: (Score:2)
An IV pump, probably not. In fact, you'd be silly to run hospital gear with a phone.
A personal device like an insulin pump... yep, I could see it. They've already got pumps that wirelessly communicate with glucometers, and a user interface written on a mobile has to be less confusing than the nests of modal menus on a pump.
Not IV Pumps (Score:2)
But perhaps they want to regulate devices such as this:
http://hardware.slashdot.org/story/13/09/21/1341212/turning-a-smart-phone-into-a-microscope [slashdot.org]
From the article:
For example, doctors in remote regions could use the technique to measure HIV viral loads in patients' blood samples, allowing the doctors to easily monitor disease progression and determine the best course of treatment."
Re: (Score:2, Interesting)
Re: (Score:1)
Here are two examples of how an app on it's own can pose significant risk to a patient, if the app is intended to make a diagnosis.
1) a medical professional prescribes an intervention that is influenced by the app's diagnosis. If the diagnosis is inaccurate, the prescribed intervention may be very harmful to the patient.
2) If the diagnosis leads to a treatment that is incorrect, the patient may be delayed from receiving the best treatment for that particular case, and this delay may be very harmful to the p
Re: (Score:2)
Re: (Score:2)
You guys should reinvent it as a UN agency so that you're not the only ones paying for it.
Are you kidding? If that happened, then the small fraction of the US that doesn't think the FDA is a Big Pharma plant will get all riled up because the AYERABS and COMMIES will control their meds.
Which, on reflection, might not be such a bad thing ...
Re: (Score:2)
actually i saw it more as a preemptive move on the FDAs part. since we dont really have tons of diagnostic sensors in our mobile devices yet...but someday we might ("Lab on a chip", etc), aka, Tricorders. so this is just them saying, if we get to that point, these apps better work, and will be regulated.
ie, none of that "You might be diseased. Click here to find out" shennanigans.
Re: (Score:2)
Except this is not preemptive. FDA has already been regulating medical applications on mobile platforms (quote, FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"). This guidance is saying that certain medical applications are now exempt from regulation.
Re: (Score:2)
i cant see any current apps being used as "medical devices". not that i know a lot about medical apps, but i dont yet know of any mobile phones being used to perform tests and provide control over treatment. far as i know the lab on a chip is still theoretical.
Re: (Score:2)
That's why FDA issued this guidance. Because they were being forced to heavily regulate simple things unnecessarily. Up until now, if you wanted a doctor to use your app, you had to get it FDA approved. Now, assuming your app meets one of the exemptions, doctors can use your app more easily without potential liability (doctors tend to be paranoid about what they'll use on patients).
Re: (Score:2)
The important fine print omitted by the summary (and very nearly the article; way to push the important information to the last third ya damn flamebaiters masquerading as journalists) is that they targeting apps
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
Now, we'll have to see how it plays out, to be sure. Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible. However, they generally allow anything with sufficient
Re: (Score:2)
a free/cheap pulse monitor simply impossible
I don't think phones need to be attached to anything to do that, but that's beside the point, as how I read the document things such as this heart rate monitor [f-droid.org]
Re: (Score:2)
Right. But since being overweight has just been re-classified as a disease, any app that lets you track you weight can be interpreted as being one that is involved in the "treatment or prevention of disease." Don't you think they won't.
The other thing I like about this is that they have a scheme for registering and tracking these devices. See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm [fda.gov] for details.
This is the Globally Unique Device Identifier (GUDID),
Re: (Score:2)
Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible.
Every treadmill I've ever seen includes a heart rate monitor. Usually when I try to use them I get readings of 0...or 500...or some other equally absurd number. Clearly things like heart rate monitors are not very strictly regulated.
Re: (Score:2)
Totally! We all agree that the FDA is one of the most ridiculous, intrusive examples of a nanny state imaginable.
Signed,
- Monsanto, Pfizer, GlaxoSmithKline, Philip Morris, Tyson, and 100s of other companies fined for marketing and selling tainted, dangerous, or untested products to consumers
Nobody has addressed the real issue (Score:1)
The FDA is protecting traditional medical device manufacturers an their exorbitant, overpriced tech to prevent vastly cheaper apps from disrupting the high cost of health care and allowing the average person to monitor their health at home for pennies a day.
Re:Woohoo! (Score:4, Insightful)
Nanny State to the rescue!
Bullshit, regulating medical devices isn't being nanny-state, outlawing marijuana is. I, for one am damned glad that the FDA had to approve the device they inserted surgically into my eyeball. I'm damned glad that drugs are regulated, so I won't underdose or overdose on a needed medicine because a supplier is incompetent or dishonest.
Do you scream "nanny state" when the cops go after armed robbers? Did you scream Nanny State when they jailed Madoff?
Sorry, kid, but your comment is just brain-dead stupid. Read a little history, look up "patent medicine" and "snake oil". Read Upton Sinclair's The Jungle (public domain, it's at gutenberg).
Re: (Score:2)
Yeah...it's almost as if the FDA is doing a good job.
Here come the disclaimers (Score:3)
Stating the app is only for entertainment/educational purposes only.
Re: (Score:2)
Will this really protect the consumer (Score:2)
Or just be another black hole that taxpayer dollars funnel into?
[Think medical device fraud via Medicare/Medicaid that is STILL rampant]
Re: (Score:2)
part of the ruling says that companies have to disclose where they get their data from. if they are lifting data from copyrighted works they will have to admit it and get sued
HIPPA (Score:1)
it could...
ex: iphone app for diabetics...you test your blood on a dongle conncted to the phone and the data gets sent via internet to your doctor's office or to a parent
if you don't check or your blood sugar goes below a set limit the system sends txt message reminders to you/your parents/your doctor
this data is covered by HIPPA [wikipedia.org]
HIPPA has privacy rights built in, but I've also read it has some back doors for doctors to share info w/ big pharma
it's not perfect but it's *
obv. u knew what i meant (Score:2)
you still got the point so i don't care
do you have any thoughts on the subject to contribute or are you just trolling?
Never go full retard (Score:2)
And tax them accordingly? (Score:4, Informative)
Would they then be subject to the O-care medical device tax? Let's not forget what it was all about to begin with.
http://www.youtube.com/watch?v=r2Kevz_9lsw
http://www.youtube.com/watch?v=BLiexzoAq7E
Re: (Score:2)
Re: (Score:2)
same here, with help from margaritas (Score:2)
Same here. Margaritas also played a key role.
Had I been smarter, I would have made my own fertility app that said "its time" whenever _I_ wanted to have some romance .
LH Surge is more reliable (Score:2)
While I use My Days to track my wife's cycle, you can have improved accuracy using an LH strip. It's a "pee in a cup, stick strip into pee for three seconds, let dry for five minutes" test.
The beautiful thing is that the LH surge happens very reliably, 24-48 hours before ovulation. (see the third chart in this link and note how narrow the blue peak is compared to the other charts: http://upload.wikimedia.org/wikipedia/commons/c/c8/Hormones_estradiol%2C_progesterone%2C_LH_and_FSH_during_menstrual_cycle.svg [wikimedia.org]
FDA scrutiny still gets Windows BSOD on devices... (Score:2)
Re: (Score:2)
The Daily WTF. [thedailywtf.com]
Their Error'd [thedailywtf.com] series is chock full'o this kind of failage.
The only risk is that someone's already submitted a screenie of any given inappopriate BSOD, but the only way to know is to try. Or read it through first.
Re: (Score:2)
Apple TOS Covers this already (Score:2)
7.5 YOU FURTHER ACKNOWLEDGE THAT THE iOS SOFTWARE AND SERVICES ARE NOT INTENDED OR SUITABLE FOR USE IN SITUATIONS OR ENVIRONMENTS WHERE THE FAILURE OR TIME DELAYS OF, OR ERRORS OR INACCURACIES IN, THE CONTENT, DATA OR INFORMATION PROVIDED BY THE iOS SOFTWARE OR SERVICES COULD LEAD TO DEATH, PERSONAL INJU
Re: (Score:2)
This is pretty standard for the silicon already.. (Score:2)
FWIW, most of the electronic components IN a phone are also sold with a disclaimer like that. Typical example here:
http://www.analog.com/en/content/analog_devices_terms_and_conditions/fca.html [analog.com]
Use in Life Support and Other Critical Applications
Products sold by Analog Devices are not designed, intended or approved for use in life support, implantable medical devices, transportation, nuclear, safety or other equipment where malfunction of the Product can reasonably be expected to result in personal injury, death, severe property damage or severe environmental harm. Buyer uses or sells Products for use in such critical applications at Buyer's own risk and agrees to defend, indemnify and hold harmless Analog Devices from any and all damages, claims, suits or expenses resulting from such use.
I'm pretty sure that any smartphone app-based system isn't exactly going to be a critical care/life support type of device, though.
Re: (Score:2)
You pay a differing price dor those types of uses.
Re: (Score:2)
Medical software can have 3 types of use:
-records display (display of data)
-diagnostic (take your temperature)
-therapeutic (shock your heart or cut tissue)
You see many companies jumping up and down, claiming to want in the medical space, but they usually are talking about records display only.
Re: (Score:2)
OR WEAPONS SYSTEMS.
Well, great, I guess now I'll never get my iMissileLauncher....
Protection racket (Score:2)
Stop, wait, reverse that (Score:2)
This new guidance *relaxes* the regulations, meaning that the barrier to entry for releasing a medical app has been lowered. Before Monday, if you wanted to sell a medical app on a mobile platform, you needed FDA approval. As of Monday, large swaths of medical apps are no longer required to comply with Federal Drug and Cosmetic Act.
Re: (Score:1)
Re: (Score:2)
I kinda sorta work in this industry, so I already knew about this guidance. In fact, I kinda sorta knew it was going to happen before it was official. So I didn't really have to read the article. :)
Re: (Score:1)
You need to differentiate between apps distributed in the USA and those elsewhere in the world. FDA only has control over the US of A. They will claim control (and to the best of my knowledge they have control) over the distribution of free-software (described by this final guidance) within the USA.
Re: (Score:2)
Re: (Score:1)
That app will most definitely be subject to regulation. I speak from personal knowledge :(
Re: (Score:2)
The headline is misleading. It implies that this is about *beginning* to regulate medical apps. In reality, medical apps have ALWAYS been regulated. The new guidelines issued by FDA *relax* the regulations, meaning that some medical apps no longer require FDA 510K approval. I have a feeling that OP's "read, parse, and analyze data" app will fit into that category, as of Monday.
This is actually a big deal to people who already have 510K. It used to be that you could say, "yeah I'm 510K" and you were one
Re: (Score:2)
I'd like to get the raw data to build my own plots, the vendor response is that the FDA will not let them do that, the best they can export is a pdf.
The vendor is lying.
So what if... (Score:2)
Re: (Score:2)
What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?
Source code != App. STL != part. They say they will control apps. Not your problem.
Regulation Of Knowledge (Score:2)
is the first step to eliminating it.
"Biofeedback" software (Score:1)
Re: (Score:1)
Overreach? (Score:1)
Software is not special just because it's mobile. (Score:4, Interesting)
DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.
Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [fda.gov], dated 2005.
So, yes, apps with a medical purpose are medical devices, just like any other piece of software.
Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.
This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.
AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.
And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.
THIS IS RELAXING REGULATIONS (Score:2)
It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.
FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"
FDA has ALREADY been regulating medical apps. For a long time. The proble
Re: (Score:2)
The fact that Google Play is run by an American company is not the issue.
Whether or not your app is available to be downloaded in the US is. Because you're importing your app into the US to be used by Americans.
But that's a side issue. EVEN BY AUSTRALIA'S STANDARDS your app likely qualifies as a medical device [tga.gov.au]. If you're not already registered with the Ministry of Health as a medical device manufacturer, I would highly recommend contacting someone to confirm with them whether your app should be regulate