FDA Regulation of Mobile Medical Devices and Apps

New Guidance On When Your App Crosses The Medical Device Line

February 10, 2015


Jake M. Holdreith


Member of the Executive Board

Jamie R. Kurtz


Co-Chair, Health Care Litigation Group

Do you know whether your mobile electronic device, app, or web application is regulated by the FDA? Simple devices like smartphones, device lights, cameras, informational apps, and image displays can become regulated medical devices based on how they are promoted. And the burden is on you to know if you are regulated and to comply. At the same time, FDA has issued guidance that excuses a significant segment of applications and devices from regulation, even though they are medical devices. This webinar will review the guidance and provide insight into when your mobile devices, app or web application may or may not require you to register with FDA and comply with medical device regulations.