Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA

Morgan Lewis FDA partner Michele Buenafe will speak on "Is My Digital Health Product a Medical Device?" at FDLI's Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA.

Not all digital health products in the healthcare space meet the definition of a medical device. We’ll use examples to help understand the definition and how it applies to different use cases for software.

Topics will include:

• Definition of medical device
• Agency enforcement discretion
• Case studies/examples