Wanted: FDA App Enforcement

I need help figuring this out. A pretty innovative guy named Myshkin Ingawale of Biosense Technologies, Mumbai, India two weeks ago stood in front of the audience at TED (Technology, Education and Design) in Los Angeles and announced that he was introducing through Apple’s App Store an app that lets you test your urine. It got quite a bit of attention among the blogs with plenty of jokes about having to pee on your iPhone.

It actually sounds quite cool. No, you don’t pee on your iPhone, but rather you do the test mostly the old-fashioned way of peeing into a cup and then inserting a test strip. All the app does is objectively read the results using the camera on the phone. According to a company press release, the plan is to make the app available from the App Store for 0.99 cents and the uChek kit consisting of the uChek color mat to calibrate the app plus 5 sample urine dipsticks for $19.99 through the company’s Web site.

Myshkin Ingawale, TED 2013. Photo by Ryan Lash, copyright TED. 

So here’s my question: doesn’t this app fall within longstanding FDA regulation for urinalysis? I’ve been practicing medical device law for almost 30 years, and I’m having a tough time understanding how this app is not regulated.

It seems to me that the company must be aware of the potential for FDA regulation, because on its home page, at the very bottom, after extolling the clinical uses of its product to monitor disease, the company says:

“However it should be noted that uChek is intended to be used for health and wellness information purposes and as a demonstration of technology. It is not intended to be used for diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease and should not be used as a medical device.”

Everyone in the medical device industry probably recognizes that the company is trying to distinguish its intended use from one meeting the FDA’s medical device definition.

So really, is that all it takes to avoid FDA? That seems pretty easy, and probably won’t impede sales very much, given that the company also has the following statements on its Web site, more prominent than the disclaimer:


“uChek is a smartphone application which enables you keep track of your health by monitoring your urine. uChek simplifies the process of urine analysis using conventional dipsticks. Urinalysis using dipsticks can give you data on up to ten anylates in urine like glucose, protein, ketones, blood, pH, specific gravity, urobilinogen, bilirubin, leukocytes and nitrites. uChek can help you analyse, interpret and trend your urinalysis data to help you understand and manage diseases like diabetes and its, urinary tract infections and pre-eclampsia.”

On a page where the company explains what urinalysis is, the company states:

“Your urine can tell you many things about your health & analysis of certain physical & chemical characteristics can help you detect presence or absence of several medical conditions. Using a urine dipstick along with uChek can help you detect presence of up to 25 diseases - diabetes, pre-clampsia, urinary tract infection, etc. to name a few.”

Indeed, the company goes on to name those diseases in both a blog post and press release available on the Web site.
Looks like I’ve been going about this all wrong. I’ve been telling clients they need to genuinely intend a lawful use for their products, and not simply try to sell their products for medical use, while disclaiming that same use in boilerplate legalese.

To be clear, this is a different issue than one Rep. Fred Upton (R-MI) and others recently raised with FDA in a recent letter. In that letter, the Congressmen asked FDA about the extent to which FDA will consider the actual use of a mobile app by purchasers, as compared to the manufacturer’s intended use. Sometimes, despite a manufacturer’s best efforts to be clear about its intended use, lo and behold customers use it for something different. But here I am raising the question of what is Biosense Technologies’ true intended use for their app, as revealed by their website? It’s not hard to figure out.

Further, it couldn’t be any clearer that instruments used for urinalysis are indeed medical devices, and in particular class I. The device classification regulation, 21 CFR Sec. 862.2900 Automated urinalysis system, clearly establishes FDA regulates urinalysis systems:

“An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.”

So here’s the problem. There are all sorts of companies out there trying to do this kind of stuff right. They follow the rules, and that costs money. In the case of the Class I device that means using a quality system to make sure the device actually does what it’s supposed to do. It would appear that this company wishes to avoid using the quality system, registering, reporting adverse events and doing all the other things that bona fide medical device companies do.

This app will sell for about 20 bucks. Companies that employ a quality system will probably have to charge more than that to make a decent return. How can a company lawfully compete with those that are willing to try to avoid FDA regulation with a simple disclaimer?

Yes, FDA has not published its final guidance on mobile medical apps. But so what? It certainly doesn’t need to publish that guidance to enforce the statute and a 26 year old regulation that requires FDA compliance for a urinalysis test.
On the one hand, it might seem like I’m picking on this company. But frankly, it is simply typical of what we are seeing day in and day out show up in the various app stores.

At the end of the day, these rules are there for a reason. People get hurt when medical devices do not possess the quality they need to reliably perform their functions. If this test, for example, under reports or over reports an analyte, a person might be lulled into believing they don’t have a medical condition when in fact they do. For diseases like diabetes, that can have deadly consequences. Of course, if FDA regulation is no longer necessary for urinalysis, I’m sure everyone in that business would appreciate FDA rescinding that regulation.

In my business, one of the worst things that can happen is a law on the books that is not enforced. That puts every ethical company in a dilemma -- do you sink to the level of your competition that seems to be getting away with flaunting the laws, or do you stick to your ethical guns.

Since the TED presentation just occurred, obviously FDA has not had time to respond. It will be interesting to see what they do.

FDA has an unenviable task. With the floodgates opening to a torrent of new mobile medical apps, it’s difficult to fathom how FDA will keep up on the enforcement side. With app stores as a means of distribution, any company can quickly launch a new product in a very big way. To enforce these laws, FDA has the burden to develop evidence of a violation, which may be especially complicated and expensive when the developers are located overseas.

But right now it is also very expensive for companies to stick to their ethical guns. Every week companies walk into my office and ask me if they can do something, and if I tell them that FDA regulates their app, chances are they can point to a half a dozen out there that are doing the exact same thing without complying with FDA requirements. What do I say to them?

FDA is going to need to develop an enforcement process that is fair, efficient and effective. On the one hand, I’d hate to have that responsibility myself, because fairness costs money and money’s in short supply. But on the other hand, I hate to see these ethical companies struggling mightily while trying to do the right thing. There must be a better way.

Brad Thompson is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. He also heads up the firm's Connected Health Initiative, and blogs for mobihealthnews.com. 
 

 

 

 

 

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