FDA Explains Process for Denial of Certificate to Foreign Government for Devices

Posted August 20, 2018

The Food and Drug Administration (FDA) is accepting comments until Oct. 16 on draft guidance explaining why the agency may deny issuing a Certificate to Foreign Government (CFG) to medical device manufacturers—and what they can do about it.

The draft guidance, “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” was released in mid-August. “The guidance, when finalized, will provide more transparency to the medical device industry and foreign governments on FDA’s decision-making for a Certificate to Foreign Government denial, the process to request a review of the denial, and how to contact FDA staff with other questions,” the FDA said in a statement.

Foreign governments may require firms exporting FDA-regulated devices to provide a CFG stating that their devices comply with U.S. laws and can be legally marketed and distributed in the United States, according to the FDA.

According to the draft guidance, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) may deny a CFG due to an injunction, seizure action, or device recall, or if an establishment is out of compliance with FDA’s Quality System Regulation (also known as current Good Manufacturing Processes (cGMPs), as stipulated in the Federal Food, Drug, and Cosmetic (FD&C) Act, or for other reasons.

Under the FD&C Act, the agency should not deny a CFG request based on FDA inspectional observations, according to the draft guidance. “Additionally,” the draft guidance states, “the FDA does not intend to deny a CFG based solely on observations documented in a report issued to an establishment that participates in an audit program in which the United States participates or recognizes, if the FDA and the owner, operator, or agent in charge of such establishment have agreed to a plan of correction in response to the report.”

Industry comments will help shape the FDA’s thinking on this topic. Comments on the draft guidance can be submitted to the Federal Register docket number FDA-2018-D-2310.

For questions about CFGs, contact:

  • CBER Import and Export Staff within the Office of Compliance and Biologics Quality (OCBQ), Division of Case Management (DCM) at: CBERBECATS@fda.hhs.gov