Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Ruth Bediakoh
Consumer Safety Officer
Postmarket and Consumer Branch
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Ruth Bediakoh is a Consumer Safety Officer in the Postmarket and Consumer Branch, Division of Industry and Consumer Education (DICE), Office of Communication and Education (OCE), Center for Devices and Radiological Health (CDRH). She assists with DICE’s efforts to educate and inform the medical device and radiological health industry on its FDA regulatory requirements for marketing medical devices and radiation-emitting products. Ruth has been with the FDA since 2015. Before joining DICE in 2019, she was an Export Certificate reviewer for medical devices and prior to that, she was a regulatory health project manager in FDA’s Center for Tobacco Products. Ruth has a Bachelor of Science degree from Pennsylvania State University.
Abstract
Ruth Bediakoh’s presentation outlines the FDA’s medical device export certificate program. She clarifies that while export certificates are not legally required to export medical devices from the U.S., foreign governments or customers frequently request them as proof of a device’s regulatory and marketing status in the United States to facilitate international trade. CDRH issues several certificate types, including the Certificate of Foreign Government (CFG) for legally marketed devices exported from the US, Certificates of Exportability (C801, C802) for certain devices not legally marketed in the US but exportable under specific statutory sections, a Non-Clinical Research Usefulness certificate (NCR), and the recently authorized Certificate of Foreign Government for devices Not Exported from the United States (CFG-NE). The CFG-NE can be issued for devices manufactured and shipped between foreign countries, provided they meet requirements such as being legally marketed in the US and manufactured in substantial compliance with cGMP. Recent program enhancements include issuing all certificates electronically as downloadable PDFs for efficiency and including a QR code on certificates for quick and easy validation by foreign entities. Certificates are valid for two years. Key advice provided includes determining the specific requirements of the importing country, noting that FDA cannot provide this information, being cautious when requesting multiple certificates with country-specific names listed, printing electronic certificates within 45 days of issuance to avoid resubmission and fee, and monitoring application progress for timely responses to FDA requests.