Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number

What You Need to Know? 👇

What is FDA Variance No. 5 for medical device reporting?

Variance No. 5 allows manufacturers with multiple reporting sites to use the Facility Registration Number of the reporting site instead of the manufacturing site when completing MedWatch form 3500A for adverse device reports.

When can manufacturers use a reporting site’s registration number instead of the manufacturing site’s number?

Manufacturers can use this variance when they have one or more reporting site locations. However, they must still list the manufacturing site’s registration number and address in Block G1 of form 3500A.

What format should the manufacturer report number follow under Variance No. 5?

The report number must include the reporting site’s facility registration number, followed by the 4-digit calendar year when the report was submitted, and end with a 5-digit sequence number.

Who has authority to approve variances from standard MDR reporting formats?

The FDA’s Center for Devices and Radiological Health (CDRH) has authority under 21 CFR Part 803.19(c) to approve variances from standard manufacturer report number formats for adverse device reports.

Where should manufacturers direct questions about FDA reporting variances?

Manufacturers should contact the Reporting Systems Monitoring Team at (301) 594-2735, fax (301) 827-0038, or email rsmb@cdrh.fda.gov for questions about reporting variances and requirements.

What information must still be included when using Variance No. 5?

Even when using the reporting site’s registration number, manufacturers must include the manufacturing site’s registration number and complete address in Block G1 of the MedWatch form 3500A.

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What You Need to Do 👇

Recommended Actions

1. Review current MDR reporting procedures and determine if using this variance would benefit your organization
2. If implementing the variance:
   • Update internal procedures to use reporting site facility registration number
   • Ensure proper documentation of manufacturing site information in Block G1
   • Train relevant personnel on the new report number format
3. Maintain records of implementation and compliance with the variance requirements
4. Contact the Reporting Systems Monitoring Team if clarification is needed

Key Considerations

Other considerations

• Manufacturer report number format must include:
  • Reporting site facility registration number
  • 4-digit calendar year of report submission
  • 5-digit sequence number
• Manufacturing site registration number and address must be listed in Block G1 of form 3500A
• This variance is authorized under 21 CFR Part 803.19(c)

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Relevant Guidances 🔗

• Medical Device Reporting: Manufacturer Report Number Format Variances
• Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers

Related references and norms 📂

• 21 CFR Part 803.19(c): Medical Device Reporting - Exemptions, variances, and alternative reporting requirements

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Original guidance

• Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
• HTML
• Issue date: 1996-08-11
• Last changed date: 2021-04-27
• Status: FINAL
• Official FDA topics: Medical Devices, Postmarket
• ReguVirta ID: cb76a42ca5279df5003b29fa7268fa65