- What is the 510(k) and how is it different from a Pre-market application (PMA)?
- What are the Code of Federal Regulations (CFRs) and how do they affect the general and special requirements of specific medical devices?
- What are the 3-letter product codes assigned to devices and what do they mean?
- How and when is a Q-Sub useful?
Let’s start with untangling nomenclature and understanding how the United States Food and Drug Administration (US FDA) regulates medical devices.
This workshop takes a deep dive into the fundamentals of the US FDA regulatory framework and identify the difference in approach to EU requirements.
We will use interactive case studies to better understand the practical applications of the submission pathway and process and discuss the basic expectations of the 510(k) and Pre-submission packets - what does and doesn’t belong in a Pre-Submission? What are the manufacturer and FDA expectations in a Pre-submission meeting?