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