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

Wednesday, September 9, 2020
12:15 PM - 01:00 PM ET
09:15 AM - 10:00 AM PT

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