Falls Church, VA (PRWEB) September 30, 2013
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.
On Sept. 25 the FDA released its final guidance regulating medical device mobile apps. Some of industry’s concerns were addressed and some were not.
If you have questions, and who doesn’t… what can 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.
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WHO SHOULD ATTEND
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
EASY WAYS TO REGISTER
By phone: 888-838-5578 or 703-538-7600