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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.

  1. Review current MDR reporting structure to identify if any of the four variance scenarios apply to your organization
  2. 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
  3. Wait for FDA assigned reporting numbers before implementing new numbering system
  4. Update MDR procedures to reflect any granted variances and new numbering systems
  5. Train relevant personnel on new procedures and numbering systems
  6. Implement tracking system to ensure proper use of assigned numbers and sequence numbers
  7. Maintain documentation of variance approval and assigned numbers

Key Considerations

Other considerations

  • 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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