Medical Device Product Code Usage and Requirements
This guidance describes how device product codes are used by FDA to regulate and track medical devices throughout their total product life cycle. It covers devices described in the existing classifications under 21 CFR Parts 862-892, including devices licensed under the Public Health Service Act, unclassified devices, and devices not yet classified.
What You Need to Know? 👇
What are FDA medical device classification product codes and why are they important?
Classification product codes are 3-letter combinations that FDA uses to internally classify and track medical devices. They help identify device types, support regulatory decisions, connect databases throughout the product lifecycle, and ensure accurate communication between industry and FDA for submissions, adverse events, and compliance actions.
How do I find the correct product code for my medical device?
Search the FDA Product Classification Database at accessdata.fda.gov using device name, regulation number, or intended use. If no suitable code exists, contact the appropriate CDRH/CBER review division or submit a 513(g) Request for Classification to obtain guidance on proper classification.
Can product codes change after my device receives FDA clearance or approval?
Yes, product codes can evolve due to technology changes, reclassification, or regulatory updates. FDA will issue corrected clearance/approval letters when codes change and notify affected manufacturers in writing. Obsolete codes remain in databases for tracking purposes and valid predicates.
What happens if I use an incorrect product code in my submission?
FDA reviewers will correct inaccurate product codes and notify applicants. Using wrong codes can cause delays in delivery, shipment, or regulatory communication. Always verify the primary product code from your clearance/approval letter for all postmarket correspondence and submissions.
Do I need different product codes for 510(k), PMA, and IDE submissions?
The same device may receive different codes across submission types. IDE codes are primarily for internal tracking and may differ from final PMA/510(k) codes. Multiple codes can be assigned to devices with different features, with the highest regulatory class becoming the primary code.
How are product codes used in adverse event reporting and recalls?
Include the primary product code in MDR section D2 and recall notifications to improve data quality and ensure proper routing. This supports regulatory requirements for device identification and helps FDA track safety issues accurately across their databases and compliance systems.
What You Need to Do 👇
Recommended Actions
- Determine the appropriate product code for your device by searching FDA’s Product Classification Database
- Include the correct primary product code in all regulatory submissions and correspondence with FDA
- Use the product code in adverse event reporting to ensure proper device identification and tracking
- Verify product code requirements for import/export activities using the ORA Product Code Builder
- Ensure proper product code usage in establishment registration and device listing
- Contact FDA Program Operations Staff if you need a new product code or corrections to existing codes
- For convenience kits, verify if your kit meets the requirements in FDA’s Convenience Kit Guidance before using a kit product code
- For export-only devices, obtain specific export-only product codes from FDA
- Keep track of any product code changes following device reclassification or other regulatory changes
- Include premarket submission numbers along with product codes in MDR reporting when applicable
Key Considerations
Other considerations
- Product codes must be used in premarket submissions (510(k), PMA, HDE, IDE) to identify and track devices
- The primary product code should correspond with the regulation and class applicable to the device
- Product codes should be used in adverse event reporting (MDRs) to ensure proper device identification
- Product codes are required for import/export activities
- Product codes must be used in establishment registration and device listing
- For convenience kits, specific product code requirements apply based on FDA’s Convenience Kit Interim Regulatory Guidance
- For export-only devices, manufacturers need to obtain specific export-only product codes
Relevant Guidances 🔗
- Medical Device Convenience Kits - Premarket Notification and Compliance Requirements
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms 📂
- 21 CFR Parts 862-892: Classification Regulation Panels
- 21 CFR Part 807: Establishment Registration and Device Listing
- 21 CFR Part 860: Medical Device Classification Procedures
- 21 CFR Part 803: Medical Device Reporting