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.
What You Need to Know? 👇
What are the main grounds for FDA denial of export certificates for medical devices?
FDA may deny CFG or CFG-NE requests for four primary reasons: ongoing injunction proceedings, seizure actions, Class I or II device recalls, or establishment non-compliance with Quality System regulations (21 CFR part 820/cGMPs).
How long does FDA take to respond to a plan of correction for export certificate denials?
FDA intends to respond to plans of correction within 90 days, though timing depends on agency resources, complexity of noncompliance issues, and establishment responsiveness. The review process may require additional clarification communications.
What information must be included when requesting review of an export certificate denial?
Requests must include: email subject line with “Request for Review” and application number, requestor contact details, establishment name/address/FEI number, reference to inspectional observations, and documentation demonstrating why denial was inappropriate.
Can devices under recall still receive FDA export certificates?
Yes, for corrected recalled products, FDA reviews correction documentation and final testing. For lot-specific recalls, non-recalled lots may receive certificates if firms sign statements confirming they won’t ship recalled lots.
What is the difference between CFG and CFG-NE certificates for medical devices?
CFGs are for devices exported from the US under section 801(e)(4)(A)(ii), while CFG-NEs are for devices not exported from the US under section 801(e)(4)(F), created by the 2023 Consolidated Appropriations Act.
How does the plan of correction process work for export certificate denials?
Establishments submit correction plans via email to FDA contacts, including steps to address violations, timeframes, and documentation. FDA reviews and notifies if sufficient. Approved plans allow CFG/CFG-NE issuance if no other denial grounds exist.
What You Need to Do 👇
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:
- Review under 801(e)(4)(E)(ii)(I) - must be requested within 60 days of denial
- Review of new information under 801(e)(4)(E)(ii)(II) - can be requested at any time
Relevant Guidances 🔗
- 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