CDRH PRODUCT CODE CLASSIFICATION DATABASE

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Product Code Classification Database

The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains classification/device names and classification codes. The classification name and product code identify the generic category of a device for FDA . The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 860-892.

These files are replaced monthly, usually on the 5th of each month.

• Search the on-line product code database
• Information on how to classify a device
• Download Product Code files -information on how to download and file description

Information on Devices Regulated by other Centers

Devices regulated by CBER (Center for Biologics Evaluation and Research)
Intercenter Agreements which are working agreements developed between the FDA Centers, outline certain categories of products and how these products have been regulated by the FDA.

Updated June 3, 2004

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Center for Devices and Radiological Health / CDRH