FDAnews Announces Medical Device Mobile Apps Virtual Conference
FALLS CHURCH, Va., Aug. 13, 2012 /PRNewswire-iReach/ -- Medical Device Mobile Apps — What Needs FDA Approval
Aug. 30, 2012, 10:00 a.m. – 4:00 p.m. EDT
FDA TO INDUSTRY: FIGURE IT 'APP' YOURSELF
Virtual Conference: Medical Device Mobile Apps — What Needs FDA Approval, Takes Guesswork Out of 'Wide Open' Regulation
The FDA is twenty years behind technology in setting clear guidelines for the regulation of exciting, but potentially dangerous, new medical device applications sprouting every day.
At last count, there were 40,000 medical applications available for download on smartphones and tablets. That number has gone up since you started reading this.
Sure, the agency is trying to catch up. It's issued a draft guidance designed to help industry understand what's regulated and what's not.
Problem is, it's a little vague. And vagueness is uncertainty. And uncertainty can be scary. What should be regulated? What's exempt? The FDA itself isn't sure yet.
But a fresh new virtual conference from industry leader FDAnews brings together the thought leaders who will take the guesswork out of meeting FDA requirements. Attendees will also learn how to harness these amazing new apps to save money, increase revenue, and stay ahead of the competition.
The FDA has left a regulatory vacuum out there. But "Medical Device Mobile Apps: What Needs FDA Approval" can help attendees use this as an opportunity to develop company-tailored answers that make business sense - and stand up to regulatory scrutiny.
"The Customer Is Waiting"
Conference Chair Tim Gee is an industry leading consultant at the center of this tangled web. Bradley Merrill Thompson is an accomplished Washington, DC, attorney and medical device expert and general counsel to the mHealth Regulatory Coalition. He was instrumental in getting the FDA to issue a draft guidance.
"This is wide open territory for FDA regulated companies," Gee says. "We're going to help attendees understand what they need to do and when they need to do it. Does your app require a 510K or full-blown approval? What's behind FDA's 'enforcement discretion' they've promised? We've got the experts to help you."
Thompson adds, "The FDA has taken some good first steps but there's much more work to be done. And unfortunately, we can't wait for FDA. We in industry are going to need to figure this stuff out for ourselves and take defensible positions until we can get more clarity from FDA. The customer is waiting."
The virtual conference is convenient to attend. All that's required is that you be in front of a computer monitor when the conference begins.
This esteemed panel of experts will be on hand to answer all of your questions. Simply submit them via email, and you'll have answers by the time the session ends.
How The Virtual Conference Works
Twenty-four hours prior to Virtual Conference Wednesday, 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.
This regulation is a moving target. That's why you'll get real-time opportunities to ask questions and get involved in the discussion. Send in queries via e-mail ... you'll have answers before you log off.
If news breaks on Virtual Conference morning, you'll hear about it before the session ends.
Meet Your Instructors:
- Bradley Merrill 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, Principal, Medical Connectivity Consulting (Chairperson)
Medical Device Mobile Apps — What Needs FDA Approval
Aug. 30, 2012, 10:00 a.m. – 4:00 p.m. EDT
Tuition: $1,297 per site — includes virtual conference registration and audio cds and transcripts
4 EASY WAYS TO REGISTER
888-838-5578 or 703-538-7600
300 N. Washington St.
Falls Church, VA USA 22046-3431
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