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The line between app and regulated medical device has been blurry since 2011, when the FDA issued its first draft guidance.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:
• What the FDA means when it uses the word health vs. wellness
• What the FDA concept of intended use signifies
• What constitutes an accessory, and which accessories does the FDA regulate?
• Implications of the Biosence letter and the FDA’s thinking going forward
• The FDA’s checklist for a successful approval best practices and red flags every devicemaker must know
• Obtaining FDA clearance identifying and addressing safety-and-effectiveness criteria
• The future of mobile medical apps: How you can work with the FDA to best serve patients
• And much more
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
• Tim Gee, Principal and Founder of Medical Connectivity Consulting and a principal consultant with Santa Rosa Consulting. He boasts more than 25 years’ experience with workflow automation via integration of medical devices with information systems and enabling technologies. Clients include healthcare providers, manufacturers and early-stage companies. Mr. Gee is 2012 recipient of the American College of Clinical Engineering’s Challenger Award.
• Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition
• Bakul Patel, Senior Policy Advisor to the Center Director, CDRH, FDA (invited)
• Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific
• Marian Lee, Partner, King and Spalding.
Who Should Attend
• Product development teams
• Research and design teams
• Legal and regulatory affairs
• Risk management and design operations
• R&D and engineering
• QA/QC staff
• Compliance officers
• Executive management
• Outside counsel.
Medical Device Mobile Apps
The Biosense Case: FDA Sends First Warning
**FDAnews Virtual Conference**
Oct. 3, 2013 10:00 am. 4:00 pm. EDT
$1,297 per site -- includes virtual conference registration and audio CDS and transcripts