The FDA released final guidance for devicemakers laying out the information it provides when it denies export certificate requests and the steps firms should take to appeal rejections.
The agency issues a Certificate to Foreign Governments (CFGs) to demonstrate that a device is approved or cleared in the U.S. and meets all regulatory requirements. The final guidance clarifies the agency’s August 2018 draft and explains in greater detail what would lead it to deny a CFG request.
Companies with recalled devices, seized devices, injunction proceedings or out-of-compliance establishments could all warrant a denial, the agency said. If the agency denies a CFG request, it will send a detailed explanation, including major violations of any noncompliant facilities with references to quality system regulations.