FDA Clarifies the Process to Appeal Rejection of Export Certificate Request
(Thursday, November 9, 2023)
When the FDA refuses to issue export certificates for certain medical devices, the requesters can appeal the process. A new guidance document released this week describes the process for such appeals. Export certificates from the FDA are critical for manufacturers’ ability to export US-approved devices to other countries and any delay could have serious commercial consequences for them. The guidance document highlights the opacity of the appeal process and will not give the manufacturers much help.
The FDA can deny a request for the Certificate for Foreign Government (CFG) when the manufacturer is undergoing legal action related to non-compliance, if the product for which the CFG is being requested is under safety-related recall, or if the manufacturing facility is not compliant with GMP requirements. None of these conditions for denial of the CFG should be surprising.
The only way a manufacturer can successfully appeal the process and/or re-apply for the CFG is by providing the FDA with evidence of having addressed the issues that led to the rejection of the request in the first place. Once the FDA agrees that the remedial actions are acceptable, it will issue the CFG.
The guidance document clarifies that the FDA does not consider denial of CFG as a “significant decision” and hence the suggested timelines for response (30–90 calendar days) will be followed “depending upon the Agency’s resources, the complexity of the noncompliance issues presented, and the responsiveness of the establishment.” All the more reason for the applicants to ensure they meet compliance standards prior to initiating export activities for which CFGs are needed.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC