FDA Product Code

What is an FDA product code?

A three-letter medical-device product code identifies a generic device category in the FDA's Product Classification Database. The code is assigned based on the device classification designated under 21 CFR Parts 862–892 and connects users to the category's classification regulation, class, review panel, premarket-submission information and applicable exemptions.

Why does the product code matter so much?

Because it operationalizes an underlying classification decision. The classification regulation and device characteristics determine the applicable regulatory controls and likely pathway; the product code records that category and helps route the device through listing, submission and FDA data systems. Product codes also appear in registration and listing, import entries, adverse-event reports and recalls. Treating the code itself as the legal reason a device needs a 510(k), PMA or exemption reverses that relationship.

How do I find the right product code?

Search the database by device name, then read the classification regulation behind each candidate. Compare its identification language and intended use with the proposed device, and inspect public decisions for similar technologies. A similar trade name is not enough. When no existing category fits, the device may need a De Novo classification or a formal or informal classification discussion with the FDA rather than a forced code selection.

Can one submission involve multiple product codes?

Yes. A multi-function device or system can implicate more than one code, while the FDA may identify one lead code for administrative routing. The correct approach depends on the functions, indications and applicable policies rather than adding codes as marketing descriptors. For entry into the United States, the code used in submissions, listing and import data should stay consistent with the FDA's classification and authorization records.