Medical Device Mobile Apps The Biosense Case: FDA Sends First Warning
Product Details
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 will release its final guidance regulating medical device mobile apps. Some of industry’s concerns will be addressed and some will 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:
- 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 Biosense 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.
It’d be well worth your time to hop a flight to Washington for this standout event. Fortunately, that’s not necessary. The entire conference is being webcast in real time onto your desktop, saving you precious days away from work.
You’re certain to have questions as the day unfolds. That’s no problem. Shoot ‘em in via email. You’ll have answers by the time this six-hour conference concludes.
You’ll save money, too. Book a conference room or an auditorium and invite as many participants as you like. There’s only one low registration fee per site. It’s easy to add additional locations too, at bargain rates. Simply call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about multisite discounts.
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
Here’s How It Works
Twenty-four hours prior to the Virtual Conference on Thursday, attendees will receive all presentations.
Then, just log on to the Virtual Conference website and dial a toll-free number, both provided in your registration confirmation. And relax. That’s all there is to it.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Don’t take unnecessary risks. Sign up today for this timely learning event.
- Stress-free! No airport security hassles, no 4 a.m. wakeups, no anonymous hotel rooms. You never even leave your building — not even your own desk.
- Interactive! Constant opportunities to ask questions and get involved. Send in queries via e-mail ... you’ll have answers before you log off.
- Up-to-the-minute! Every speaker operates in the real world, in real time. If news breaks on Virtual Conference morning, you’ll hear about it before the session ends.
- Great value! Spread the word! There’s no limit on number of attendees per site. One low registration fee covers them all. Or register three or more locations for deeper discounts still. Get details here.
Agenda - Click here to print the agenda.
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference Tim Gee, Chairperson |
10:15 a.m. – 11:00 a.m. |
What Does the FDA Consider a Regulated App? Understanding the FDA’s Final Guidance, Enforcement Discretion and Definition of Accessories Attendees will learn:
Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition |
11:00 a.m. – 11:45 a.m. |
FDA’s Use of Enforcement Discretion Attendees will learn:
Bakul Patel, Senior Policy Advisor to the Center Director, CDRH, FDA (invited) |
11:45 a.m. – 12:30 p.m. |
Break |
12:30 p.m. – 1:15 p.m. |
Successful FDA Clearance: A Case Study on Designing, Developing and Commercializing a Mobile Medical Application Attendees will learn:
Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific |
1:15 p.m. – 2:15 p.m. |
Lunch |
2:15 p.m. – 3:00 p.m. |
Beyond FDA: Emerging Regulations, Risks and Rewards from FTC, FCC and States Attendees will learn:
Marian Lee, Partner, King and Spalding |
3:00 p.m. – 3:45 p.m. |
Driving Adoption of Mobile Apps for Medical Device Connectivity and Remote Healthcare: Top Trends Attendees will learn:
Tim Gee, Principal, Medical Connectivity Consulting |
3:45 p.m. – 4:00 p.m. |
Closing Comments and Adjournment Tim Gee, Chairperson |