European Union’s Proposed UDI System to Align with FDA Regulation

May 13, 2013
0 Comment

European Union’s Proposed UDI System to Align with Forthcoming FDA Regulation Read Article → read more →

International Device Task Force Recognizes HIBC for UDI

May 13, 2013
0 Comment

International Device Task Force Recognizes HIBC for UDI Read Article → read more →

HIBCC’s Unposted GHX UDI Blog

April 30, 2013
0 Comment

Read HIBCC’s yet unposted GHX blog on UDI. Read Article → read more →

PMPNews Recalls 20 Years Reporting on Auto-ID

April 30, 2013
0 Comment

In recognition of the 20th anniversary of Pharmaceutical & Medical Packaging news, HIBCC CEO Robert A. Hankin weighs in on the advancements in automated identification technologies through the last two decades of their reporting. Read Article → read more →

Hankin Discusses UDI on PMPNews.com

October 9, 2012
0 Comment

An identification standards body speaks out on the draft regulation for medical devices. Read Article → read more →

HIBCC Guideline: Understanding FDA’s Proposed UDI Requirement

September 1, 2012
0 Comment

What is a UDI and the GUDID? The Unique Device Identifier (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. On September 24, 2013 the Food and Drug Administration (FDA) established a UDI system that requires manufacturers to include both a plain-text version of the identifying data, and.. read more →

Updated Registered HIBC Labelers

August 30, 2012
0 Comment

The following companies (and/or their subsidiaries/divisions) have applied for a Labeler Identification Code (LIC) assignment with HIBCC or one of our international affiliates. By doing so, they have demonstrated their commitment to patient safety and logistical efficiency for their customers, the industry and the public at large. Any organization that is interested in using the.. read more →

FDA Proposed UDI Regulation Released for Public Comment

July 10, 2012
0 Comment

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new.. read more →

FDA Proposes Unique Device Identification

http://www.pmpnews.com/news/fda-proposes-unique-device-identification
July 3, 2012
0 Comment

FDA clarifies its proposed mandate, but still has 35 questions for stakeholders. FDA has issued its proposed rule that would require most medical devices distributed in the United States to bear a unique device identifier (UDI). FDA believes that its proposal would “reduce medical errors,” enable “more rapid, more efficient” recalls, and “lead to more.. read more →

ANSI/HIBC 5.0 Syntax Standard

April 12, 2012
0 Comment

Automatic identification technology is continually evolving. As technological advances prove applicable to the health care industry, they will be incorporated into revisions of this standard, wherever possible. However, every attempt will be made to maintain the existing data structures, thereby allowing new technology to be introduced into systems in a non-disruptive manner. HIBCC recognizes that.. read more →