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Review Process for Denied Export Certificates for Medical Devices

This guidance outlines the process for reviewing FDA's decision not to issue Certificate to Foreign Government (CFG) or Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) for devices manufactured in FDA-registered establishments. It details the information FDA will provide when denying such certificates and the review process available to those denied.

  1. Review compliance status with Quality System regulation before requesting CFG/CFG-NE
  2. If denied, carefully review the substantive summary provided by FDA
  3. Prepare and submit a comprehensive plan of correction if denial is based on QS non-compliance
  4. Submit request for review within 60 days if challenging the denial decision
  5. Maintain documentation of all corrective actions taken
  6. Consider submitting new information for review if additional corrective actions are implemented after denial
  7. Ensure all communication with FDA includes required reference information (application number, FEI, etc.)
  8. For recalls, maintain clear documentation of corrected lots and testing results
  9. Establish process for monitoring and responding to FDA communications regarding export certificates

Key Considerations

Other considerations

  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR Part 7: Enforcement Policy

Original guidance

  • Review Process for Denied Export Certificates for Medical Devices
  • HTML / PDF
  • Issue date: 2023-11-03
  • Last changed date: 2023-11-03
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket, Import, Export
  • ReguVirta summary file ID: 455f4e4bf0eec05923a255684cf09d55
This post is licensed under CC BY 4.0 by the author.