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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.'"
Nanny State to the rescue! Did someone appoint Bloomberg to the FDA?
Stating the app is only for entertainment/educational purposes only.
Or just be another black hole that taxpayer dollars funnel into?
[Think medical device fraud via Medicare/Medicaid that is STILL rampant]
Some days it's just not worth
chewing through my restraints.
Just as certain applications for other specific fields may need to pass testing and scrutiny before being available for general use (flying and the FAA comes to mind), so it is reasonable for the FDA to step in here.
App to app app gets apped after app kills 500 people, causing app apper to app apps.
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
"Now, I doubt any of you would prefer a rolled up newspaper as a weapon against a dictator or a criminal intruder."
How many software applications can say that?!
"My Days"
Helps track ovulation cycles to aid (or prevent) pregnancy.
Also helps track when the horrible PMS monster will emerge.
Witnessed this myself at the birth ward when my wife gave birth last month. Took a photo of a health monitor BSOD while giggling in the hallway, but haven't posted it anywhere. Isn't there a website where you can post BSOD's in funny places?
"Now, I doubt any of you would prefer a rolled up newspaper as a weapon against a dictator or a criminal intruder."
http://www.youtube.com/watch?v=oAKG-kbKeIo
I think Apple's terms of service says it all and that all medical apps need tossed out since they would break the tos of the device. Or am I missing something. http://www.apple.com/legal/sla/docs/iOS7.pdf
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 INJURY, OR SEVERE PHYSICAL OR ENVIRONMENTAL DAMAGE, INCLUDING WITHOUT LIMITATION THE OPERATION OF NUCLEAR FACILITIES, AIRCRAFT NAVIGATION OR COMMUNICATION SYSTEMS, AIR TRAFFIC CONTROL, LIFE SUPPORT OR WEAPONS SYSTEMS.
Paul: Father... father, the sleeper has awakened! - Dune
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 have a look.
The Daily WTF.
Their Error'd 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.
Welcome to the Panopticon. Used to be a prison, now it's your home.
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 .
Can't have cheap apps cutting into the business of big campaign donors.
So what if I create a free software app that serves some medical purpose? Am I required to get FDA approval first? What if I refuse and the FDA tries to initiate an enforcement action against me and forces me to stop distributing it? How have the courts been ruling on free software as a free speech issue?
I have a blood glucose meter that works fine all by itself (for a one day reading), if you plug it in to an iDevice you can get all of the readings, graphs, reports, etc.
Should that app be regulated? I think it is today, but does it need to be? It is only a convenience, it does not control anything or provide recommendations or diagnosis.
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.
I need the government out of my business. I don't see how this regulation helps.
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
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 *definitely* HIPPA data...which gives the user more protection and removes the obligation to show damages in a civil case against a hacker
Thank you Dave Raggett
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
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.
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And only 55 comments? Something tells me you guys just don't get it.
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.
While writing or proofreading, didn't it at some point become apparent that your post answers an altogether different question than the one the parent is asking?
you don't escape the regulatory regime
Exactly. Ever. And that is the root of the problem.
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?
You pay a differing price dor those types of uses.
I am not merely a "consumer" or a "taxpayer". I am a Citizen of the State of Texas
is the first step to eliminating it.
---- Booth was a patriot ----
Smart phones have browsers, and browsers can go to WebMD which people use for self "diagnosis", thus every smartphone is a medical device? And if it is an app that turns it into a medical device, if I write such an app for the Iphone does apple now have to submit all their Iphones to be regulated by this because it could potentially become a medical device?
Comes to mind.... http://en.wikipedia.org/wiki/Biofeedback
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
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."
this signature has been removed due to a DMCA takedown notice
This may sound silly, but it is also very important to report the issue to the device manufacturer, if you can. The FDA sets very strict rules on how companies have to handle feedback they receive from you, so your feedback will be taken very seriously. IANAL etc.
Just because I can hook a shark from a boat, I do no offer to wrestle it in the water.
To answer your question, no. Unless you go around trying to sell those products by claiming that they have a medical benefit or control life saving devices without evidence to that effect.
I have a CPR Assistant app in the google play store: https://play.google.com/store/apps/details?id=com.chewsta.cprassist
Would these proposed regulations apply to me as an Australian, even though my app is in an American owned store?
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?
Thank you Dave Raggett
I can certainly understand wanting to qualify a mobile app that controls an insulin pump or something like that (Appendix C), but Appendix B indicates the FDA intends to regulate applications that "are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness" such as meal logs, calorie counters, exercise activity, brain games, etc. Sounds like you can kiss a whole bunch of useful apps goodbye as they get regulated out of existence.
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, 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 nothing but big government protectionism to promote and defend big medicine and big medical device manufacturers. The era of personal medical "tricorders" is at hand, and the government is doing everything possible to increase the cost of health care for the 99%. The promise and opportunity of Scanadu-like devices in combination with cheap apps threatens every major medical device manufacturer in the world, who up until now has been overcharging sick patients for the right to prevent disease and maintain their health. This is the worst thing that could happen to the patient and benefits nobody but the government and their corporate teat suckers.
I can confirm this also. I work as a software developer for a major radiotherapy manufacturer, and all of the above is absolutely true. In general we have to develop our software to fit to a superset of all global regulations - significant ones include FDA, ISO, Shonin, Chinese regulations and the list is slowly growing. The FDA are becoming more and more rigourous, which while painful for manufacturers (rigour and documentation obviously costs time to market and money), is actually nothing but good news for users of medical devices/systems!
Say goodbye to your calorie-counting app. You'll have to be at least an intern in order to be able to use anything more "sophisticatrd". Scan data-to-image apps? Sugar calc apps? Sartphone camera blood sample viewing/counting apps? Sending test results over email or messaging?
For the easier stuff, at least, would a steampunk all-analogue version loophole it?
I work in the medical software field and this is nothing new. Each of our software products is considered a medical device. I'm assuming the regulations didn't specifically cover mobile apps but this is seriously not a surprise at all. Any company developing medical software that hasn't been following FDA regulations just because they are working on a mobile platform is moronic.
I made a post without seeing yours first but yours is way better. You are absolutely correct, the FDA has always considered medical software to be a 'medical device'. Any company producing health software that wasn't following FDA regulations just because they were working on a mobile app is moronic.
Another market (healthcare) desperately needing innovation utterly snuffed out by unnecessary regulation and compliance.
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.
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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 )
I've also read (Amazon reviews, so take with appropriate amounts of salt) that if a woman has polycystic ovarian syndrome, she may not ovulate, even if she menstruates. The LH surge can tell her when she actually ovulates.
Using the LH strip in combination with My Days, you can reliably avoid or become pregnant. After a few cycles, you can tell whether My Days is correctly predicting ovulation (my wife is usually right on or a day late). Since sperm lasts up to five days, and there's some natural variations in the cycle, we generally avoid 8 days before and four days after ovulation is supposed to start. No condoms, no pill, no spermicide, and still no babies, four years running.
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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 problem is, even if all your app does is draw pretty graphs, you still needed to go through e.g. 510K certification for your application. This guidance by FDA is aimed at reducing the barriers to entry for non-critical medical applications.
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