FDA Clarifies Process for Persons Denied a Certificate to Foreign Government for a Device

Today, the U.S. Food and Drug Administration (FDA) released the draft guidance “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices”  to explain why the FDA may deny issuing a Certificate to Foreign Government (CFG) to medical device manufacturers, and what steps they can take to request a review of the denial. 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. 

Firms exporting FDA regulated devices from the U.S. may be required by foreign governments to provide a Certificate to Foreign Government that states their devices comply with U.S. laws and can be legally marketed and distributed in the United States.  As required by Food and Drug Administration Reauthorization Act of 2017, the draft guidance describes the reasons that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) may deny a CFG and explains the process for persons whose request for a Certificate to Foreign Government for a medical device is denied.

Your feedback is critical in shaping the agency’s thinking on this topic. Comments on the draft guidance may be submitted to Federal Register docket number FDA-2018-D-2310 until Tuesday, October 16, 2018. 

If you have questions regarding a device Certificate to Foreign Government, please contact the appropriate center below:

• CDRH Exports Branch within the Division of International Compliance Operations at:EXPORTCERT@CDRH.FDA.GOV

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

For questions about this draft guidance regarding CDRH-regulated devices, contact the FDA’s Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health (CDRH). Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. and 4:30pm Eastern Time or by email at DICE@fda.hhs.gov.  

For questions about this draft guidance regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

Food and Drug Administration
Center for Devices and Radiological Health