FDANews is hosting a virtual web conference on August 30th. This conference will be focused on helping to define which apps need FDA approval and the process of getting there. It will occur from 10:00 am to 4:00 pm EST.

The virtual conference will feature four speakers focusing on the trends, FDA regulations, best practices for getting app approval, and expanding apps into the clinical setting. It will give an overall impression of the burgeoning mHealth market.

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.

To register, go to the official website or call 888-838-5578.

The cost does vary, but for $1,295, access to one log-in and dial-in for the live Virtual Conference is good for unlimited participants.

Included in that price is also the ability to receive all presentation materials 24 hours before the conference begins and the opportunity to ask questions by phone and email, in addition to audio CDs, and written transcripts of the entire session.

The thought leaders at the Virtual Conference include:

  • 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)

Since the FDA is going to start regulating mobile medical apps, input on the best way to do this and what to include are all important questions. The iMedicalApps team has extensively covered this topic in the past, even having a successful mHealth chat about it.

We noted that what the FDA is very rightly concerned about apps that interpret information and, with little oversight, drive clinical decision making.

Conference Chair Tim Gee explains.

“This is wide open territory for FDA regulated companies. 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.”

Bradley Merrill Thompson further elaborates.

“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.”

Source: Press Release