To look up a product code and device class, use the medical device product classification database on the US FDA website, as follows:
Open the FDA website (https://www.fda.gov/medical-devices), scroll down to the “PRODUCTS WE REGULATE” section on the home page and click “Medical Devices” to go to the medical devices pages.
On the medical devices page, scroll down to the “SEARCH MEDICAL DEVICE DATABASES” section and click “Product Code Classification Database” to open the product classification database.
If you know the product name, enter it directly in the search box (e.g. “bronchoscope”) and click the search button to get the results for the relevant products.
In the search results, the “Product code” column shows the product code. Each code has a specific product description that companies can use to confirm the right product. For example, a bronchoscope (flexible or rigid) and accessories has product code EOQ, is a Class II device under regulation number 874.4680, falls under the ear, nose and throat panel, requires 510(k) review before marketing, and is not exempt from GMP requirements.
The search results make the device class clear: Class I is usually low-risk and generally exempt from 510(k); Class II and Class III are progressively higher risk and may require different pre-market review procedures such as a 510(k) or premarket approval (PMA).
The “Regulation Number” in the results is the numbering system the FDA uses to identify and cite specific regulatory provisions, usually corresponding to specific sections of the Code of Federal Regulations (CFR) (see the Everbiz WeChat article on how to look up US 21 CFR regulations). The regulation number lets you quickly locate the specific regulatory requirements that apply to the device and the name of the corresponding regulation.
The product code is the foundation of pre-market compliance: in processes such as premarket notification (510(k)) and premarket approval (PMA), an accurate product code is the key basis for determining device classification and assessing safety and effectiveness. In addition, predicate devices usually share the same product code as the new device; in a 510(k) submission, predicates can only be found accurately with the correct product code, and a wrong code may cause the submission to fail.
Through the regulation number, companies can clearly understand the specific regulatory requirements their products must meet, and regulators can use these numbers for enforcement and oversight, ensuring products comply with all FDA requirements.
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