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.
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
Original guidance
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