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# Inside the FDA Regulatory Process

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

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[](https://www.ketryx.com/white-papers/inside-the-fda-regulatory-process#) [](https://www.ketryx.com/white-papers/inside-the-fda-regulatory-process#)

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

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