Export Certificates for Devices: FDA Issues Draft Guidance
The US Food and Drug Administration (FDA) on Thursday released new draft guidance to explain the process by which persons can be denied a Certificate to Foreign Government (CFG) for a device and what to do if one receives a denial.The 7-page draft describes the information that FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.
Among the reasons FDA may deny a request for issuance of a CFG are:
1. There is an injunction proceeding pursuant to section 302 of the Federal Food Drug and Cosmetic Act (FD&C Act);
2. There is a seizure action pursuant to section 304 of the FD&C Act;
3. The device is the subject of a recall designated by the FDA as Class I or Class II;
4. An establishment is out of compliance with FDA’s Quality System Regulation (also known as current Good Manufacturing Practices (cGMPs)) under 21 CFR part 820.
“If FDA denies a request for a CFG for these or other reasons, the FDA will notify the requestor in writing, identify its basis for denying the request, and specifically identify the finding upon which such denial is based,” the draft says.
The owner, operator or agent in charge of the establishment should submit a plan of correction in writing to the appropriate FDA office, including steps to correct observations documented and timeframes for completing such steps. FDA says it will review the plan and provide notification of whether the plan is sufficient to address the violations. If the plan is agreed to, FDA will issue a CFG.
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Draft Guidance for Industry and Food and Drug Administration Staff