# Inside the FDA Regulatory Process

Former FDA software systems safety expert, Paul Jones, shares his insights.

Understanding the background and motivating factors for FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs personnel will help you get a better understanding of how to prepare submissions. This eBook, written by former FDA Paul Jones, addresses:

- The basic structure, training, and background of FDA personnel
- The most common mistakes he sees companies make while building and maintaining software
- What to expect during an audit, as well as good standard practices for avoiding fines and warning letters

## More resources

[White Paper  
**Discover Why Traceability Doesn't Have to Be So Hard**  
Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.  
Read more](/content/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard/index.html)

[White Paper  
**Regulatory Pathways**  
Learn about the different approval pathways possible, and how to find the one that works best for you.  
Read more](/content/white-papers/regulatory-pathways/index.html)