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FDA issues Small Entity Compliance Guide on UDI


Today the Food and Drug Administration is making available Unique Device Identification System: Small Entity Compliance Guide (SECG): Guidance for Industry and Food and Drug Administration Staff. FDA is issuing this guide 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 the regulation. The SECG represents the FDA’s current thinking on this topic.

Specifically, this small entity compliance guide is intended to explain in plain language the requirements of the September 24, 2014 UDI final rule and to help small businesses understand and comply with the regulation. It contains information on key definitions, compliance dates, and formatting requirements related to the UDI system.

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 Global Unique Device Identification Database (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 guide useful and if you have any questions related to the implementation of the UDI rule please contact the FDA’s UDI Help Desk.

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