Medical Device Mobile Apps Conference Agenda
Medical Device Mobile Apps: What Needs FDA Approval
An FDAnews Virtual Conference
Thursday, Aug. 30, 2012 • 10:00 a.m. – 4:00 p.m. EDT
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference |
10:15 a.m. – 11:15 a.m. |
Top Trends Driving the Industry Towards Adoption of Mobile Apps for Medical Device Connectivity and Remote Healthcare This presentation will focus on the top trends influencing the development of apps and provide a regulatory and strategic pathway for potential app developers. Attendees will learn:
Tim Gee, Principal, Medical Connectivity Consulting |
11:15 a.m. – 11:30 a.m. |
Break |
11:30 a.m. – 12:30 p.m. |
Successful FDA Approval Case Study: Designing, Developing and Commercializing an FDA-Approved Mobile Medical Application Attendees will learn:
Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:30 p.m. |
What Does the FDA Consider a Regulated App? Understanding the FDA’s Current Comments, Draft Guidance, “Enforcement Discretion” and Definition of Accessories Attendees will learn:
Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition |
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
Mobile Medical Applications in the Clinical Setting — Simplifying Device Connectivity, Developing Point of Care Consolidation of Device Alarms, Health and Status and Improving Process Control and Workflow Automation Attendees will learn:
Tracy Rausch, Chief Technical Officer, DocBox |
3:45 p.m. – 4:00 p.m. |
Closing Comments and Adjournment |