FDA Product code

Food and Drug Administration Product Code: A three-letter code assigned by the FDA to categorize device types.

Product codes group devices based on design, medical specialty, and technological features. The product code determines applicable regulatory requirements under 21 CFR, guidance documents, and the appropriate submission route, such as a 510(k) or De Novo.

Explore the data behind the terms

HaRi brings the FDA, MHRA, EUDAMED, Health Canada and TGA registers into one search: devices, manufacturers, product codes and safety events, all cross-referenced and free to explore.

Search HaRi→