UDI Ruling

Healthcare Reform

SMI's UDI Community Bulletin Board Submission Form

Join the UDI conversation.  Please submit your comments and questions below.  Comments will be reviewed prior to posting.

SMI's UDI Bulletin Board

On July 3, 2012 The Food and Drug Administration (FDA) released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI.   A 120-day comment period, lasting until November 7, 2012 will allow industry stakeholders to consider and comment on the challenges, issues, and opportunities related to the UDI proposed rule.

Click here to read SMI's response to the FDA's UDI rule.

 

SMI's UDI Community Bulletin Board:

(Please note: "The comments expressed in this bulletin board do not necessarily reflect the opinions of SMI, its Board of Directors, staff or members.")

UDI
Comments:
1) "The FDA's proposed UDI rule represents an opportunity to transform the healthcare supply chain in so... (07/18/2012)See More
2) "Karen Conway, Executive Director of Industry Relations at GHX has started a multi-part blog series o... (07/23/2012)See More
3) "SMI's Collaborator AHRMM has announced a Complimentary Webinar to Learn about the FDA's Unique Devic... (07/24/2012)See More
4) "Comments on the FDA UDI Ruling must be submitted, according to the FDA, by November 7 2012 and ident... (08/17/2012)See More

UDI Events:

GS1 Healthcare US presents:  FDA UDI and GS1 Standards:  Perfect Together Webinar
 

UDI Resources/More Information:

1. Access the Proposed Regulation

2. GS1 Executive Summary of the Proposed UDI Rule      

3. Read the FDA News Release

4. Read the GS1 Press Release on the FDA UDI Announcement

5. Receive email updates from the FDA

 

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