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FDAnews Announces Medical Device Mobile Apps Virtual Conference - Oct. 3, 2013
Sep 19, 2013 (01:09 PM EDT)
FALLS CHURCH, Va., Sept. 19, 2013 /PRNewswire-iReach/ -- Medical Device Mobile Apps
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The line between app and regulated medical device has been blurry since 2011, when the FDA issued its first draft guidance.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 tease out the fine points that can mean the difference between FDA approval and a warning letter. You'll discover:
From fast-changing technology to regulatory parameters, conference chair Tim Gee is ideally positioned to shed light on the complexities. Mr. Gee boasts more than 20 years of in-depth research and experience helping medical device firms manage connectivity, and developing and obtaining FDA approval for medical-device apps.
Smartphone apps hold immense promise for devicemakers — and thorny new areas of regulation and law too, as the Biosense matter illustrates. On your way to innovation, don't let regulatory hazards trip you up. Get the answers you need — now.
Meet Your Faculty
Who Should Attend
Easy Ways to Register
Media Contact: Jeff Grizzel, FDAnews, 703-538-7600, firstname.lastname@example.org
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