Agenda

MMA Roadshow: Managing App Development under FDA Regulation

8:00 a.m. – 8:10 a.m.

Welcome and Introductions

Speakers:

James Boiani, EpsteinBeckerGreen

8:10 a.m. – 8:30 a.m.

FDA Introductory Comments on the Final Mobile Medical Applications Guidance

Speaker:

Bakul Patel, Senior Policy Advisor, U.S. Food and Drug Administration

8:30 a.m. – 9:30 a.m.

Scope of FDA Regulation: Analyzing the New FDA Guidance

Speaker:

Bradley Merrill Thompson, EpsteinBeckerGreen

9:30 a.m. – 10:30 a.m.

Panel Discussion: Regulatory Strategies

Pre-Market Strategy o Predicate devices for mobile medical app premarket

notificationso Additional features: strategies for getting apps cleared

Sponsored by

Post-Market Strategyo Cost-effective ways to meet design control and other

requirements in the production of mobile medical aps

Moderator:

James Boiani, EpsteinBeckerGreen

Panelists:

Nandini Murthy, Enem ConsultingBonnie Norman, Care InnovationsTom Schady, Pathfinder SoftwareBob Michalik, RegulatoryPro Consulting

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Panel Discussion: Business Strategies for Bringing New Apps to Market

Is going into FDA regulated territory worth it? Are there strategies for partnering with others to share the

regulatory burdens? Is using contract manufacturing with an experienced medical device

company a good option? What are business strategies for reducing regulatory risk?

Moderator:

James Boiani, EpsteinBeckerGreen

Panelists:

Sponsored by

Richard Yang, DexcomBonnie Norman, Care InnovationsRosalind Picard, Massachusetts Institute of TechnologyElazer Edelman, Massachusetts Institute of Technology

12:00 p.m. – 12:30 p.m.

FDA Q&A

Speaker:

Bakul Patel, Senior Policy Advisor, Food and Drug Administration

12:30 p.m. Adjourn

Sponsored by