FDA Finalizes Guidance on Handling Device Export Certificate Denials
The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining how the agency handles denials of requests for a certificate to foreign government (CFG) for medical devices and how to request a review when a CFG is denied.Such certificates are used to assure foreign governments that a device being exported complies with US regulations, such as the Quality System Regulation (QSR).
The eight-page guidance finalizes a draft version issued in August 2018 and includes several clarifications made in response to comments received during the public consultation on the guidance.
Specifically, the guidance details the reasons FDA may deny a request for a CFG and explains that the agency will provide a substantive summary listing the major noncompliance issues that make up the basis for the denial.
Among the changes are a clarification that the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research will provide information to requestors in collaboration with the Office of Regulatory Affairs.
The final guidance also specifies that it “does not intend to deny a CFG for an establishment with a No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classification for the most recent quality system inspection.”
Additionally, the final guidance clarifies that in cases where the requestor of a denied CFG is not the owner/operator of the establishment that manufactures a device, FDA will inform the requestor that the denial is based on issues related to the manufacturer, but will only provide the substantive summary of the issues to the out-of-compliance establishment due to disclosure requirements.
For recalled products, the final guidance clarifies that FDA will base its decision on a CFG request on the current status of the recalled products, including documentation and final testing submitted to FDA as part of the recall review process.
FDA notes that in the case of lot-specific recalls, devices in other lots “may be included on a CFG provided the firm signs a statement indicating that it will not ship the lots of the product that are subject to recall.”
The final guidance also provides more details on how FDA will handle plans of correction submitted in response to a denial of CFG and specifies that it intends to respond to a plan of correction within 90 days.
Lastly, the final guidance expands on its processes for reviewing a denial of request to issue a CFG, explaining that there are “two distinct types of review” pursuant to Sections 801(e)(4)(E)(ii)(I) and 801(e)(4)(E)(ii)(II) of the Federal Food, Drug, and Cosmetic Act, providing greater detail on each type of request.
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