CATEGORY: CLASSIFICATION

FDA Product Code

A three-letter code assigned by FDA to categorize medical devices by type. Product codes determine the review panel, classification, and regulatory requirements. There are over 6,000 product codes in the FDA system.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

WHEN IT APPLIES

FDA product codes classify device types and drive regulation numbers, submission types, and guidance applicability.

PROCESS / STEPS

Search the product classification database by keywords.
Confirm three-letter product code and submission type.
Use the code for predicate search and testing planning.
Monitor competitor clearances under the same code.

EXAMPLES

OpenFDA and 510(k) databases are commonly filtered by product code for surveillance.

RELATED GUIDES & TOOLS

SOURCES

FDA Product Classification ↗

Track regulatory signals related to FDA Product Code across 27 authorities in real time.

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