Medical Device Mobile Apps The Biosence Case: FDA Sends First Warning
Product Details
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 Biosence.
Biosence 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. 23 the FDA released its final guidance regulating medical device mobile apps. Some of industry’s concerns were addressed and some were not.
If you still have questions, and who doesn’t… what can you do?
Here’s a great first step: Order the CD and Transcript Set of the one-day virtual conference, Medical Device Mobile Apps.
FDAnews 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 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 Biosence 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
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 |