FDA Releases UDI Small Entity Compliance Guide

On August 13, 2014, the FDA released a guide to the UDI rule called “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff.”

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. (- page 4.)

The FDA published a final rule on September 24, 2013, 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 13, 2013. Certain requirements within the rule have later compliance dates. Companies who must meet the UDI final rule, including makers of class III medical devices, must comply by September 24, 2014.

Download your copy of  the FDA’s Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff: August 13, 2014. (PDF – 518KB)

UDI Compliance With ID Technology

For more information about the UDI ruling and how to simply compliance, please download UDI Ebook from ID Technology. ID Technology will help you comply with the FDA’s Unique Identification (UDI) labeling, marking and automatic ID requirements. Please contact us here or call (888) 438-3242.