FDA Tells What To Do When The Export Certificate is Denied.

To export a medical device from US to another country, the manufacturers need the Export Certificate, called the Certificate to Foreign Government (CFG) to clear customs. Most CFGs are issues without much hitch but there are times when FDA denies a CFG for either the device being exported is just to injunction proceedings or seizures by FDA, is being subject to a Class I or II recall, or was found to be manufactured under non-compliant conditions. Only in the case of non-compliant manufacturing practices does the FDA allow the requester to appeal the denial of the CFG. In case the denial is issued due to non-compliance with manufacturing regulations, FDA would issue a detailed list of deficiencies to the requester. The requester can respond to the denial letter with the Correction Plan with itemized description of how the deficiencies have been addressed. FDA will respond within 30 days if it agrees that the deficiencies have been addressed and issue a CFG. All communications with FDA must be via emails. The guidance describes the process followed by FDA to address appeals to CFG denial decisions and follows a common sense approach.