Medical Device Reporting: Manufacturer Report Number Format Variances

What You Need to Know? 👇

What is the MDR manufacturer report number format required by FDA?

The manufacturer report number consists of the FDA registration number of the manufacturing site, followed by a four-digit calendar year, and a five-digit sequence number starting with 00001 for the first report each calendar year.

When can manufacturers request FDA assigned reporting numbers instead of using registration numbers?

Manufacturers can request FDA assigned reporting numbers when multiple reporting sites share the same registration number, when reporting sites share manufacturing sites, when multiple manufacturing sites share one registration number, or when the actual manufacturing site cannot be determined.

How do manufacturers apply for FDA assigned reporting numbers under the variances?

Manufacturers must submit a letter to CDRH at the address specified in 21 CFR 803.12(a), providing specific information about reporting sites and manufacturing sites, and clearly marking the envelope with the appropriate request statement for the variance type.

What should manufacturers do when they cannot determine which site manufactured a device involved in an adverse event?

Under Variance No. 4, manufacturers may arbitrarily assign a manufacturing site using any method (default site, random selection, or rotation), but must state in item H10 of Form 3500A that the actual manufacturing location could not be determined.

Which variance applies when multiple manufacturing sites share the same FDA registration number?

Variance No. 3 applies when multiple manufacturing sites share the same registration number. Manufacturers can request FDA assigned reporting numbers for each site, with one site continuing to use the official registration number.

What information must be included when requesting FDA assigned reporting numbers for multiple reporting sites?

The request must include the current registration number, complete name and address of each reporting site, MDR contact information, unique identifiers for each organization/division, and identification of which entity will use the official registration number.

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What You Need to Do 👇

Recommended Actions

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

• 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

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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

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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 ID: 37a370fa25013536134bbe902e72af1a