September 1, 2012

HIBCC Guideline: Understanding FDA???s Proposed UDI Requirement

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 […]

August 30, 2012

Updated Registered HIBC Labelers

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 […]

July 10, 2012

FDA Proposed UDI Regulation Released for Public 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 […]

July 3, 2012

FDA Proposes Unique Device Identification

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 […]

April 12, 2012

ANSI/HIBC 5.0 Syntax Standard

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 […]

February 24, 2012

ANSI Approves HIBC 5.0 Syntax Standard

The Health Industry Bar Code (HIBC) Syntax Standard has been given final approval by the American National standards Institute (ANSI). Also known as ANSI/HIBC 5.0, the standard was developed by the Health Industry Business Communications Council (HIBCC), the accredited global standards development organization that supports patient safety by creating industry-supported non-proprietary standards for healthcare product […]

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