Medical Device Mobile Apps: What Needs FDA Approval

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An FDAnews
Virtual Conference Rebroadcast

A California congressman has announced plans to introduce a bill requiring the FDA to establish an Office of Mobile Health to help speed the development and approval of device apps.

If you’re involved in medical device apps — or even thinking of getting started — this virtual conference is a must-buy.

Four speakers and 4 hours of detailed intel and a whopping 130 pages of PowerPoint slides will assure you’re getting your money’s worth.

The growth in device apps and the FDA’s definitions has created a quagmire for the FDA and industry.  Questions abound:

  • If your product needs FDA approval, is it a 510(k) or a full-blown application?
  • Will the regulations keep up with the lightning-fast app development cycle?  Some have called the FDA’s approval process stuck “in the floppy disk” era.
  • The FDA mentioned “enforcement discretion” for some apps that might not meet the definition of a covered device app, BUT might be considered a traditional medical device — what does that mean?

So how will apps get FDA approval?  How long will it take, and how much money will it cost, to manage the FDA approval process?

Register Today

Featuring four speakers focusing on the trends, FDA regs, best practices for getting approval and expanding apps into the clinical setting, this virtual conference will provide a detailed look at the emerging market for medical device apps.

Attendees will come away with ideas on how to transform their traditional devices into apps, a better understanding of what needs FDA approval and lessons learned from a firm that already has an FDA-approved app on the market.

No travel required.  Gather your colleagues for the best, and most cost effective, training in the industry.

This is your invitation to log on Wednesday, Oct. 31, and discover what’s really necessary to develop an FDA-compliant medical device app.  Please note; this virtual conference has been previously recorded and no questions will be taken during the presentation.

Your Virtual Conference Rebroadcast chairperson is Tim Gee, principal and founder of Medical Connectivity Consulting and a principal consultant with Santa Rosa Consulting. Mr. Gee has more than 25 years of experience working with providers and manufacturers on workflow automation through the integration of medical devices with information systems and enabling technologies.

Mr. Gee, along with other top professionals, will teach you:

  1. How to decipher the general parameters of the scope of FDA regulation of mobile medical apps
  2. What the FDA means when it uses the words “health” versus “wellness”
  3. The FDA’s concept of intended use — is clarification needed?
  4. Accessories, accessories, accessories:  What are accessories and which accessories does the FDA regulate?
  5. When the FDA regulates decision-support software found in a mobile app
  6. How to address the challenges and barriers to market entry for a medical device manufacturer
  7. Obtaining FDA clearance — identifying and addressing the safety and effectiveness criteria
  8. How to become a strategic supplier — using an app to leverage your company strategy
  9. Where the future of mobile medical apps is moving.  How will the FDA, devicemakers and clinical organizations work together to best serve patients?

Register Today

The Virtual Conference Rebroadcast is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Everyone in your organization with a role in product development, legal and regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

Sign up for Medical Device Mobile Apps: What Needs FDA Approval today. Please note; this virtual conference has been previously recorded and no questions will be taken during the presentation.

  • 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

Register now

Meet Your Instructors

  • Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition
  • Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific
  • Tracy Rausch, Chief Technical Officer, DocBox
  • Tim Gee, Connectologist and Principal, Medical Connectivity Consulting (Chairperson)

Here’s How It Works

Twenty-four hours prior to the Virtual Conference Rebroadcast on Wednesday, attendees will receive all presentations.

Then, just log on to the Virtual Conference Rebroadcast 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.
  • Great value! Spread the word! There’s no limit on the number of attendees per site. One low registration fee covers them all. Or register three or more locations for deeper discounts still.
Date: Wednesday, Oct. 31, 2012
Location: Your office or conference room (no need to travel!)
Time: 12:00 p.m. – 4:00 p.m. EDT
  11:00 a.m. – 3:00 p.m. CDT
  10:00 a.m. – 2:00 p.m. MDT
  9:00 a.m. – 1:00 p.m. PDT
  5:00 p.m. – 9:00 p.m. BST

Gather your team for maximum benefit! Your investment is for one dial-in.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
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