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Just Released: FDA’s UDI Draft Guidance Document

The FDA issued a new, guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”

You may have received an email from the FDA with the announcement of the draft guide. This guide is designed to make sure your labels and data are in compliance with the UDI labeling for medical devices and packaging.

Here is a copy of the email:

CDRH Industry: FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)  07/25/2016

Today, the U.S. Food and Drug Administration released a draft guidance document, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).” The Unique Device Identification System Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text and automatic identification and data capture (AIDC) technology forms. UDIs must be issued under a system operated by FDA-accredited issuing agencies (IAs).

This draft guidance is intended to assist both labelers and FDA-accredited IAs better ensure the UDIs developed under IA systems are in compliance with the UDI rule. It includes clarification on:

Two forms of a UDI;

  • Content of the UDI (including data delimiters that identify specific data elements within the UDI); and
  • Order of data in a UDI and UDI carrier (the means to convey the UDI and any non-UDI elements in easily readable plain-text and AIDC forms).

We welcome your comments regarding this draft guidance. The comment period closes in 60 days.

For more information about the Unique Device Identification System, please visit the FDA’s UDI webpage.

If you have any questions, please contact the FDA UDI Help Desk.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

If you are involved with UDI labeling at your company, you will want to download our ebook ID Technology Guide Labeling and Marking Compliance. ID Technology has put together this ebook to help explain and simplify UDI labeling and data structures.

Printing technology for FDA UDI labelingID Technology can help you reach UDI labeling compliance and provide solutions for other labeling challenges in manufacturing and packaging of medical device products. Read more on Labeling News here or contact us today – 888-438-3242 Option#3 or you can contact David Holliday directly at  dholliday@idtechnology.com. We’ll get you in touch with one of our ID Technology specialists in your area.



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