Product Codes & Regulation Numbers
US-unique
The FDA product code system is a US-specific classification mechanism. Every regulated device type has a unique three-character product code that links it to a specific regulation, panel, class, and submission type.
What is a product code?
A product code is a three-character alphanumeric identifier (e.g., FRN, DQO, IYO) assigned by FDA to a specific device type. It appears in:
- FDA's Product Classification Database
- 510(k) and PMA submission databases
- GUDID device records
- FDA's MAUDE adverse event database
What information a product code tells you
For each product code, FDA's database provides:
| Field | What it means |
|---|---|
| Device name | The formal name of the device type |
| Device class | I, II, or III |
| 21 CFR Part | The applicable classification regulation |
| Submission type | Exempt, 510(k), PMA, or De Novo |
| Review panel | The advisory panel (e.g., Cardiovascular, Radiology) |
| Regulation number | Specific section within the 21 CFR Part |
| GMP exempt | Whether QMS (QMSR) applies |
| Third party review | Whether abbreviated third-party 510(k) review applies |
How to find your product code
- Go to FDA Product Classification Database
- Search by:
- Device name — use descriptive terms, not brand names
- Product code — if you already know it
- 21 CFR section — if you know the regulation
- Review panel — browse all devices in a specialty
- Review the results and identify the most applicable product type
Using product codes in submissions
When filing a 510(k) or PMA, you must correctly identify the product code. FDA uses it to:
- Route the submission to the correct review team
- Apply the appropriate performance standards and special controls
- Determine applicable MDUFA review timelines
Selecting an incorrect product code is a common technical deficiency that can delay acceptance of a 510(k).
When no product code exists
If your device type has no existing product code, you have two main options:
- De Novo classification request — creates a new product code, device type, and classification order
- Contact CDRH via a Q-submission (pre-sub meeting) to discuss classification before submitting