Navigation Links
FDAnews Announces Medical Device Mobile Apps Virtual Conference - Oct. 3, 2013

FALLS CHURCH, Va., Sept. 19, 2013 /PRNewswire-iReach/ -- Medical Device Mobile Apps
The Biosense Case: FDA Sends First Warning
**FDAnews Virtual Conference**
Oct. 3, 2013 — 10:00 a.m. – 4:00 p.m. EDT  


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The line between app and regulated medical device has been blurry since 2011, when the FDA issued its first draft guidance.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:

  • 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.

Register 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
  • Manufacturing
  • R&D and engineering
  • QA/QC staff
  • Compliance officers
  • Executive management
  • Outside counsel

Conference Details
Medical Device Mobile Apps
The Biosense Case: FDA Sends First Warning
**FDAnews Virtual Conference**
Oct. 3, 2013 — 10:00 a.m. – 4:00 p.m. EDT 

$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

Media Contact: Jeff Grizzel, FDAnews, 703-538-7600,

News distributed by PR Newswire iReach:

Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDAnews Announces The Insiders Guide to Supplier Quality Success DVD
2. FDAnews Announces Leading the Climb: Seven Essentials of GMP Workshop
3. FDAnews Announces Medical Device Risk Management Conference, July 11-12, 2013, Boston, MA
4. FDAnews Announces Clinical Quality Assurance Workshop
5. FDAnews announces Biopharmaceutical Good Distribution Practices Summit
6. FDAnews announces Fifth Annual Risk Management & Drug Safety Summit
7. FDAnews announces Third Annual Pharmaceutical Labeling Summit
8. FDAnews Announces Medical Device Mobile Apps Virtual Conference
9. FDAnews announces Fourth Annual Supplier Quality Congress
10. Pro-Dex, Inc. Announces Fiscal 2013 Fourth Quarter And Full-Year Financial Results Conference Call And Webcast
11. Rafarma Pharmaceuticals, Inc. (RAFA) announces plans for PCAOB-Registrant Audit and Streamlining of Corporate Structure to Upgrade Market Listing.
Post Your Comments:
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... ...
(Date:9/28/2017)... 2017 Cohen Veterans Bioscience and Early Signal ... wearable and home sensors for real-time monitoring of patients ... a nonprofit organization focused on disruptive health solutions for ... analytical system to record and integrate behavioral, cognitive, physiological ... ...
(Date:9/27/2017)... Israel and NEW YORK , Sept. 27, ... with mobile health and big data solutions, today announced that its MyDario ... Please check your local TV listings for when The Dr. Oz Show ... ... season this month. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... 12, 2017 , ... Planet Fitness, one of the largest and fastest growing ... open a flagship location in Covington, LA at 401 N. U.S. Highway 190, in ... to Office Depot in the Holiday Square shopping center. Its location allows it to ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... Restoration, has recently contributed a medical article to the newly revamped Cosmetic ... Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... On Saturday, ... a treadmill relay – Miles by Moonlight to raise money for the American Heart ... or more. , Teams will work together to keep their treadmills moving for ...
Breaking Medicine News(10 mins):