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 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 timeframe for certain devices. In developing the proposed rule, FDA 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 2013.

Over the past year, FDA has been working on the design and development of the Global Unique Device Identification Database (GUDID).

This document is intended primarily to provide information about submitting data to the database for device Labelers, entities who will be responsible for providing the data to the GUDID. Please note that database enhancements will 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. The FDA intends to periodically update this document to reflect system changes and enhancements.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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