Understanding the US FDA Device Classification System

Navigating the FDA Classification System - a White Paper by Emergo

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Ready to sell your medical device in the United States? The first step is to classify your device according to the US FDA classification system. And as many medical device manufacturers know – this is not an easy task.

The US FDA uses a complex predicate system, and misclassifying your device can be a costly and time-consuming mistake. Knowing the correct classification of a medical device is critical for identifying its proper regulatory route in the United States. Emergo has successfully classified thousands of devices in the US, and we discuss the US classification process in this 13-page white paper. You will learn:

  • How to search the FDA predicate database?
  • How to interpret three-letter product codes and seven-digit regulation numbers?
  • How incorrect classification can lead to unnecessary testing?
  • Common pitfalls in searching the FDA database?
  • Why your Class I or II exempt device might require a 510(k)?

We answer all of these questions and many more in this white paper.

Stuart Goldman is a Senior RA/QA Consultant at Emergo.