Guidance for Industry and Food and Drug Administration Staff

Unique Device Identification System: Small Entity Compliance Guide

Document issued on August 13, 2014

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 Food and Drug Administration Amendments Act of 2007 (FDAAA) and section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs FDA to publish regulations establishing a unique device identification system for medical devices.

On September 24, 2013, FDA published a final rule establishing a unique device identification system (the UDI Rule). Some parts of the rule became effective on October 24, 2013; the remaining parts became effective on December 23, 2013. Certain requirements within the rule have later compliance dates, as will be explained in Section VI of this document. In developing the UDI 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.

This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s September 24, 2013, final rule establishing a unique device identification system; see 78 FR 58786 et seq. It provides an overview of the UDI Rule’s regulatory requirements and discusses the actions a small entity should take to meet those requirements. Other guidance documents, such as the guidance document titled Global Unique Device Identification Database (GUDID) and issued on June 25, 2014, discuss in greater detail the technical implementation of the UDI Rule.

Throughout this guidance document, the terms “we,” “us” and “our” refer to FDA staff from CDRH and the Center for Biologics Evaluation and Research (CBER). “You” and “your” refers to the labeler. 

Download FDA Guidance Below.

Download “UDI Small Entity Compliance Guide” ucm409401.pdf – Downloaded 146 times – 420 KB

Last Updated: 2015-08-17