“Medical Devices” & FDA’s Regulatory Framework
Patricia Kaeding
Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)
Nathan A. Beaver
Partner
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