Introduction
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).
This document is primarily intended for device labelers and provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID).
This guidance update reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. Since April 2019 the GMDN Agency allows access to GMDN Terms without a paid membership. Therefore, the option to use FDA Preferred Term (PT) Codes is no longer necessary and FDA intends to remove them from GUDID. Reference to the FDA PT codes is being removed from this guidance and GUDID users must use GMDN codes (21 CFR 830.310(b)(13)). Database enhancements to improve user experience, build in better validation rules, and other changes may continue as we receive feedback. We intend to periodically update this document to reflect system changes and enhancements.
In general, FDA’s guidance documents 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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