FDA Issues New Guidance on Responding to Denials of Certificates to Foreign Governments
The Food and Drug Administration on Nov. 14 issued a new guidance document on procedures for reviewing FDA denials of export certificates for medical devices. The guidance document details the process for exporters to correct deficiencies that caused FDA to deny issuance of a Certificate to Foreign Government (CFG) for a device, as well as for requesting agency review of denials.
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The process for exporters denied CFGs was mandated by the FDA Reauthorization Act of 2017. The certificates act as official assurance for foreign governments that products exported to their countries are in compliance with U.S. law or meet specific U.S. regulations, such as Quality System Regulations. FDA may deny requests for CFGs where there is an ongoing injunction proceeding, seizure action or recall, or where the establishment is out of compliance with FDA’s Quality System Regulation (aka, current good manufacturing practices), though FDA does not intend to deny CFGs for establishments “with a No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classification for the most recent quality system inspection,” the agency said.
FDA will generally notify the requestor by email when a request is denied, outlining the reason for the denial and, if denied because of lack of compliance with CGMPs, a substantive summary of the grounds for non-compliance. If the CFG is denied based on a problem at an establishment that has a different owner/operator number than the exporter, the exporter will still be notified but will not be given the detailed reasoning behind the denial, which will instead be sent to the establishment.
Exporters may submit a plan of correction after receiving a summary of the grounds for non-compliance. If the plan is determined to be sufficient, a CFG application still under review or subsequently submitted to FDA will be approved.
Exporters can also request formal reviews of a denial, with an opportunity for supervisory review and a meeting or teleconference. Alternatively, a review may also be requested to present new information, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by FDA, the agency said.