Unique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff August 2014

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

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). While some parts of the rule became effective on October 24, 2013 and some became effective on December 23, 2013, most requirements within the rule have later compliance dates, as will be explained in Section A.2. 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 document provides clarification of key provisions of the UDI Rule.

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