The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, the nation’s food supply, cosmetics, dietary supplements, and products that give off radiation; and for regulating tobacco products.
Section 226 of the FDA Amendments Act (FDAAA) of 2007 and section 614 of the FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs the FDA to promulgate regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices.
The Unique Device Identifier (UDI) Proposed Rule was published on July 10, 2012, followed by an amendment, published on November 19, 2012, modifying the implementation time frame for certain devices. In developing the proposed rule, we solicited input from a variety of stakeholders (e.g., manufacturers, global regulatory bodies, the clinical community, patient advocates) to ensure that as many perspectives were incorporated as possible. The UDI Final Rule was published on September 24, 2013 (78 FR 58786).
Global Unique Device Identification Database (GUDID). Document issued on December 17, 2024.