FDA Regulations on Mobile Medical Apps

Posted On

Are you aware of the FDA Regulations on Mobile Medical Apps? FDA recently issued the Mobile Medical Applications (MMA) Guidance for Industry and Food and Drug Administration staff on Sept 25, 2013. The document outlines the agency’s regulation of mobile medical apps as devices and their intent to focus only on the apps that present a greater risk to patients.

This topic may not seem related to Quality by Design in the BioPharmaceutical Industry. However whether you manufacture drugs, therapies or medical devices, you may be planning to extend indications, collect clinical data or communicate directly with patients around your product offerings through a mobile app. If this is the case, you may be keenly interested on FDA’s guidelines on the new mobile platform. This workshop focused on answering those questions for app developers in or close to FDA regulated territory. In four hours, speakers, panelists and the audience took a deep dive into the regulatory issues associated with bringing new mobile apps into the healthcare space. The workshop clarified many issues but also raised many questions from the industry and regulatory professionals.

This MMA Roadshow was hosted by the Stanford University’s Biodesign and Epstein Becker Green (Credit) at the heart of Silicon Valley.

The topics addressed were:

How to figure out the appropriate classification in a system for those apps that FDA does regulate.
If your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence.
Practical steps for developing an FDA quality system that is nuanced to fit mobile apps, and is designed to be as economical as possible.
In a global economy, what are the differences between the US regulatory system and the EU system, and how can a company efficiently enter both markets?
From the perspective of seasoned executives, what are the management challenges you can anticipate in mobile app development in a regulated environment?
How to develop mobile apps that come as close to the FDA line as possible, but don’t cross over into regulated territory.

Some tips shared were:

The benefit of contacting FDA early
Importance of Risk Assessment and Clinical Equivalence
Postmarket issues and how to prepare for them.
Business models and Reimbursement strategy of Medical Apps
How much people are willing to pay for Mobile Medical Apps.
How to deply Agile in a regulated environment

Scroll to the bottom of the page to download the slides, documents and audio.

AGENDA

8:15 a.m. – 8:25 a.m.		Welcome and Introductions Speakers: Paul G. Yock, MD, Director, Stanford Biodesign Kim Tyrrell-Knott, Epstein Becker Green
8:25 a.m. – 8:45 a.m.		FDA Introductory Comments on the Final Mobile Medical Applications Guidance Speaker: Bakul Patel, Senior Policy Advisor, U.S. Food and Drug Administration
8:45 a.m. – 9:40 a.m.		Scope of FDA Regulation: Analyzing the New FDA Guidance Speaker: Kim Tyrrell-Knott, Epstein Becker Green
9:40 a.m. – 10:30 a.m.		Panel Discussion: Regulatory Strategies Pre-Market Strategy Predicate devices for mobile medical app premarket notifications Additional features: strategies for getting apps cleared Post-Market Strategy Cost-effective ways to meet design control and other requirements in the production of mobile medical aps Moderator: Bethany Hills, Epstein Becker Green Panelists: Jafar Shenasa, Proteus Digital Health Shilpa Mydur, Glooko Andrea Ruth, ALR Consulting Peggy McLaughlin, Clinical and Regulatory Consultant
10:30 a.m. – 10:45 a.m.		Break
10:45 a.m. – 11:15 a.m.		EU Regulatory Update: Strategies for Global Regulatory Compliance Speaker: Erik Vollebregt, Axon Lawyers, Amsterdam, The Netherlands
11:15 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: Bethany Hills, Epstein Becker Green Panelists: Tapan Mehta, Cisco Systems Walter De Brouwer, Scanadu Mohit Kaushal M.D., Aberdare Ventures Sudhi Gautam, Vector Asset Management Morgan Reed, Association for Competitive Technology (ACT)
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