- What is the 510(k) and how is it different from a Pre-market application (PMA)?
- What is 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?
- How and when is a Q-Sub useful and is it the same as a Pre-Submission?
Let’s start with untangling nomenclature and understanding how the United States Food and Drug Administration (US FDA) regulates medical devices.
This workshop tackles fundamentals of the US FDA regulatory framework and we look into the basic expectations of the 510(k) and Pre-submission packets - what does and doesn’t belong in a Pre-Submission? Are there similarities between the US FDA submission documents and the EU submission requirements?