Overview of Device Regulation

July 21, 2016 8:00am

What is it about?

  • Navigating 21 CFR part 800, et seq.
  • What is a device and how is it different from a drug?
  • Understanding the concept of risk-based classification and the three main classes (I, II, and III) of medical devices
  • 513(g) Requests
  • Combination Products
    • Definition
    • Process for designations
    • Options for seeking a combination product
    • How to get the correct classification for a product
    • Implications of getting a product classified as a device or a drug
  • Registration and listing
    • Who must register and submit a device list and what information must be included?

Session Materials