FDA Reprimands First Mobile App
In a first last week, FDA issued a warning to developers of a mobile healthcare app.
In an "It Has Come to Our Attention Letter"* issued to India-based Biosense Technologies, FDA voiced its concerns around the uChek Urine Analyzer app and invited the company to discuss the topic further.
(*It probably "came to their attention" from hype delivered via TED Talk and subsequent Mashable article, "This App Will Test Your Pee," from February of this year. Also, according to MobiHealthNews, the app was mentioned as an example of one that FDA is failing to regulate during recent congressional hearings.)
The uChek app is designed to help patients read reagent strips (manufactured by Siemens and Bayer) for urinalysis, including, according to the FDA letter, "glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity." In a nutshell, the uChek app allows users to analyze their urinalysis dipsticks at home via mobile phone.
But FDA felt that the app (and in fact the entire system) should be classified as a device because, while Siemens’ and Bayer’s urinalysis dipsticks are cleared by FDA, analyzing them via mobile app is not.
FDA issued draft guidance in 2011 around mobile medical applications. This is the first direct citation of a mobile medical app since then.
Stifling Innovation Through Regulation?
This article from Libertarian publication Reason Magazine felt the citation is an example of FDA stifling innovation through regulation.
But I’m not sure I agree.
I don’t know much about Biosense or their clinical rigors. I expect they made attempts to make the app as safe and as accurate as possible. And according to the uChek website, they’ve been successful in gaining attention from BBC, Wired, TechCruch, CNET, and more.
But does that mean the app is accurate? That there’s little chance for error?
Who knows? And that’s exactly FDA’s point.
I doubt Seimens nor Bayer endorsed the app to be used with their strips. I do know the pharma/healthcare industry has a poor enough reputation without being associated with rogue mobile apps that could cause patients harm. Time will tell if Biosense decides to go through with a 510(k) submission.
Yes, the FDA 510(k) submission approval process adds layers of complexity and cost to development of apps for use by patients or professionals. By design, it is the most stringent type of device marketing application required by FDA.
But if it’s truly an innovative app that fills a need and will be valuable to patients, the effort of 510(k) clearance will be worth it. And if the FDA review process helps ensure patients stay safe while using FDA-cleared mobile apps, bring it on. In fact, they should consider some kind of Good Housekeeping-esuqe FDA seal of approval.
In the words of Myshkin Ingawale, co-founder of Biosense Technologies, "Everybody pees, and everybody carries a cellphone."In the words of FDA (not really) …. "Everyone is making mobile apps, and everyone must make sure they are safe."