FDA-Regulated Research Track
2019 AER Conference
B04 - Investigational Device Exemptions (IDE) Mobile Medical Applications and IRB Review
Soma Kalb, PhD
Director, Division of Clinical Science and Quality, Center for Devices and Radiological Health, US Food and Drug Administration
Bakul Patel, MSEE, MBA
Director, Digital Health, Center for Devices and Radiological Health (CDRH) Food and Drug Administration
James Riddle, MCSE, CIP, CPIA, CRQM
Vice President, Institutional Services & Strategic Consulting, Advarra, Inc.
Speaker(s)
In general, the IDE regulations apply to clinical investigations of medical devices designed to determine safety and effectiveness. When do you need an IDE for a clinical investigation of a medical device? What about mobile applications? When does a mobile application meet the definition of a medical device under the Food, Drug, and Cosmetic Act, and how does FDA intend to apply its regulatory authorities to mobile medical applications? IRBs may struggle with these questions and what their review responsibilities are when a protocol involves a mobile medical application. During this session, speakers and attendees will:
Learning Objectives:
- Share a basic overview of the applicability of the IDE regulations that address when an IDE is required
- Distinguish when mobile applications meet the definition of a medical device
- Discuss FDA’s current approach to applying its regulatory authorities to oversight of mobile medical applications
- Provide IRBs with a review framework for studies involving mobile medical applications and suggest policies and procedures to develop to ensure HRPPs remain relevant in a tech savvy world