Medical Device Reporting: Manufacturer Report Number Format Variances
This guidance addresses the format of Manufacturer Report Numbers in Medical Device Reporting (MDR), specifically providing variances to handle situations where the standard format (FDA registration number + year + sequence number) creates challenges for manufacturers with multiple reporting or manufacturing sites.
Recommended Actions
- Review current MDR reporting structure to identify if any of the four variance scenarios apply to your organization
- If applicable, prepare and submit appropriate variance request letter(s) to FDA including:
- Clear identification of which variance is being requested
- Required information for each specific variance
- Proper labeling on the mailing envelope
- Wait for FDA assigned reporting numbers before implementing new numbering system
- Update MDR procedures to reflect any granted variances and new numbering systems
- Train relevant personnel on new procedures and numbering systems
- Implement tracking system to ensure proper use of assigned numbers and sequence numbers
- Maintain documentation of variance approval and assigned numbers
Key Considerations
Other considerations
- Four specific variances are provided for different scenarios:
- Variance 1: Multiple reporting sites at same location sharing registration number
- Variance 2: Multiple reporting sites using same manufacturing site
- Variance 3: Multiple manufacturing sites sharing same registration number
- Variance 4: Cases where manufacturing site cannot be determined
- Each variance requires specific documentation and submission process
- FDA will assign unique reporting numbers when applicable
- For unknown manufacturing sites, manufacturers must indicate in Form 3500A item H10 that the actual place of manufacture could not be determined
Relevant Guidances
- Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms
- 21 CFR 803.3(o): Medical Device Reporting - Definitions
- 21 CFR 803.19(c): Medical Device Reporting - Exemptions, variances, and alternative reporting requirements
- 21 CFR 803.12(a): Medical Device Reporting - Where to submit reports
Original guidance
- Medical Device Reporting: Manufacturer Report Number Format Variances
- HTML
- Issue date: 1996-07-15
- Last changed date: 2021-04-27
- Status: FINAL
- Official FDA topics: Medical Devices, Adverse Event Reporting System (FAERS)
- ReguVirta summary file ID: 37a370fa25013536134bbe902e72af1a
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