Overview of Device Regulation
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
- 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?