FALLS CHURCH, Va., Sept. 19, 2013 /PRNewswire-iReach/ -- Medical Device Mobile Apps
The Biosense Case: FDA Sends First Warning
**FDAnews Virtual Conference**
Oct. 3, 2013 — 10:00 a.m. – 4:00 p.m. EDT
Smartphone technology opens a new world for medical device innovation. It also opens a can of worms with the FDA. Could you get in trouble?
A smartphone app that can analyze urine is a really smart app. Indeed, it isn't an app at all: It's a medical device.
Or is it? That's the question troubling devicemakers everywhere, now that the FDA has made an example of Biosense.
Biosense markets an app called uCheck that checks urine levels of blood, protein and other substances, using dipsticks and an iPhone camera to record and analyze results. The dipsticks are OK; it's the dipstick-plus-phone combo that's the problem. Together, asserts the FDA, they constitute a new medical device.
The line between app and regulated medical device has been blurry since 2011, when the FDA issued its first draft guidance. Now, everyone from app designers to Congress is awaiting the final guidance, expected this fall.
Meantime … what do you do?
Here's a great first step: Register now for the one-day virtual conference, Medical Device Mobile Apps.
FDAnews has invited an authoritative FDA voice, Baku Patel of CDRH, plus four top private-sector lawyers and devicemakers for an intensive one-day virtual conference examining this fast-changing area where innovation and regulation collide.
Speakers will lay out how the FDA approaches regulation of mobile medical apps, then t
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