FDA Product Code Directory

The FDA assigns a three-letter product code to every type of medical device it regulates. Each product code corresponds to a specific device category with a defined intended use, device class (I, II, or III), and regulatory pathway.

Product codes are essential for determining the regulatory requirements for a medical device, including whether a 510(k) premarket notification, PMA application, or De Novo classification is needed. They also determine applicable special controls, GMP requirements, and labeling standards.

Use this directory to browse all product codes or the 510(k) Predicate Finder to search for specific clearances within a product code.