“Medical Devices” & FDA’s Regulatory Framework

July 27, 2017 8:30am

Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)

Nathan A. Beaver
Foley & Lardner LLP

  • What is a “Device”?
  • Differentiating medical devices from drugs and non-medical devices
  • The 3 risk-based classes of medical devices
  • Overview of FDA regulation of devices & paths to market for devices
  • Understanding combination products: definitions, processes, strategies & implications
  • Working with FDA’s Center for Devices & Radiological Health
  • Office of Regulatory Affairs realignment