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.
Recommended Actions
- Review compliance status with Quality System regulation before requesting CFG/CFG-NE
- If denied, carefully review the substantive summary provided by FDA
- Prepare and submit a comprehensive plan of correction if denial is based on QS non-compliance
- Submit request for review within 60 days if challenging the denial decision
- Maintain documentation of all corrective actions taken
- Consider submitting new information for review if additional corrective actions are implemented after denial
- Ensure all communication with FDA includes required reference information (application number, FEI, etc.)
- For recalls, maintain clear documentation of corrected lots and testing results
- Establish process for monitoring and responding to FDA communications regarding export certificates
Key Considerations
Other considerations
- Grounds for denial include:
- Ongoing injunction proceedings
- Seizure actions
- Class I or II recalls
- Non-compliance with Quality System regulation (21 CFR part 820)
- FDA must provide notification of denial with specific reasons
- A plan of correction can be submitted to address non-compliance issues
- Two types of review processes are available:
- Quality System Information Requirements for Premarket Submissions
- Design Controls for Medical Device Manufacturers
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
Related references and norms
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 7: Enforcement Policy
Original guidance
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