FDA issues Guidance on the Unique Device Identification System: Frequently Asked Questions, Vol. 1

Today the Food and Drug Administration is making available Unique Device Identification System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this document as level 2 guidance consistent with FDA’s good guidance practices regulation. While Level 2 guidance documents are posted for immediate implementation, comments on any guidance document may be submitted by following the instructions in theregulation. This guidance represents the FDA's current thinking on this topic.

Specifically, this guidance is intended to summarize key aspects of the UDI final rule, as identified through inquiries frequently submitted to the FDA UDI Help Desk. It addresses UDI basics, UDI placement, the Global Unique Device Identifier Database (GUDID), and direct marking, as well as exceptions, alternatives and exemptions.

At its most basic, the Unique Device Identification System requires device labelers (usually manufacturers) to include a unique device identifier (UDI) on the labels and packages of medical devices distributed in the United States, unless the FDA grants an exception or alternative. The UDI must be displayed in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology – companies frequently have chosen to use a bar code. The UDI Rule also requires labelers to submit specified product information to FDA’s GUDID. Implementation of the rule will be phased in over seven years. For information on the benefits of the Unique Device Identification System please see the UDI website.

We hope you find this guidance useful and if you have any questions related to the implementation of the UDI rule please contact the FDA’s UDI Help Desk.