Use of Reporting Site Registration Number for Medical Device Reports (MDR) Instead of Manufacturing Site Number
This guidance document outlines a specific variance (V1996005) that allows medical device manufacturers to use the Facility Registration Number of reporting sites instead of manufacturing sites when submitting adverse medical device reports (MDRs) using MedWatch form 3500A.
Recommended Actions
- Review current MDR reporting procedures and determine if using this variance would benefit your organization
- 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
- Maintain records of implementation and compliance with the variance requirements
- 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)
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
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 summary file ID: cb76a42ca5279df5003b29fa7268fa65
This post is licensed under CC BY 4.0 by the author.