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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
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. UDI initiatives are also underway globally -- the European Commission released a framework for a UDI System in April 2013; the International Medical Device Regulators Forum (IMDRF) UDI Work Group issued a guidance document on UDI in December 2013.
This document is primarily intended for device Labelers, and provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID). A draft version of this document wasreleased on September 24, 2013 with a 60 day comment period, which ended on November 25, 2013. More than 300 comments were received from 21 entities. In order to provide labelers access to the latest information as soon as it is available, and address sections that received the most comments and questions, sections of this document were previously finalized and released on June 11, 2014. This current iteration of the document finalizes the remaining sections and incorporates sections finalized earlier, in order to provide one complete and final document.
Please note that database enhancements may continue to improve user experience, build in better validation rules, and make other necessary changes as we “learn” from the initial roll-out and implementation. We intend to periodically update this document to reflect system changes and enhancements.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0636.