Declaration on US FDA UDI for Medical Devices Supplying to the US Market

More and more countries are adopting laws which require companies that manufacture, label or distribute medical devices to be identified with a “unique device identifier” (UDI).  UDI is a unique device identification system established by the United States Food and Drug Administration (FDA) to adequately identify medical devices sold in U.S.  As an accredited issuing organisation for UDI by the U.S. FDA, GS1 is required by law to declare to the U.S. FDA on annual basis on companies using GS1 barcode numbers to identify medical devices that they (or their affiliates) are selling in the U.S. market under their label.

About U.S. FDA UDI Regulatory Requirements

GS1 standards meet the U.S. FDA’s criteria for issuing UDIs. GS1 Member Organisations across the world will help manufacturers implement with the requirements of the U.S. FDA UDI regulation, to support patient safety and supply chain security.  Regulated product data must be submitted to the Global Unique Device Identification Database (GUDID), i.e. the U.S. FDA UDI regulatory database.  By the rule of FDA, if your product is under the scope of medical devices and will supply to the U.S. market, please declare by completing the form “Declaration on U.S. FDA UDI”

U.S. FDA UDI Rule: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

U.S. FDA UDI Final Rule on Unique Device Identification System

If your products (e.g. surgical masks, gloves, toothbrush & etc.) are under the scope of medical devices and will supply to the U.S. market, you are required to declare.  

For details, please refer to the UDI Appendix

For scope of medical devices in U.S., please visit https://www.fda.gov/medical-devices