How does FDA regulate mobile medical applications? What should companies consider when designing and promoting mobile medical apps? This program will discuss FDA’s Mobile Medical Applications final guidance. Topics include the FDA’s regulatory oversight of mobile medical apps, e.g., software used on smart phones, tablets and other devices. This session will discuss the latest updates from FDA relating to mobile Medical apps. They will walk you through many real-world examples. Come prepared with your questions. Questions answered include:
When does your mobile app become a medical device?
When does FDA consider your mobile app a consumer product which it will not regulate?
How does FDA determine not to regulate one app versus another?
How does the new guidance impact industry?
What is FDA's position on the cybersecurity and mobile medical applications?
What if you add a mobile medical application to an existing medical device or tie it to the delivery of a pharmaceutical?