HIBCC - Welcome to the Health Industry Business Communications Council

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.

target="_blank">Read Article →

The post PMPNews Recalls 20 Years Reporting on Auto-ID appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.

Hankin Discusses UDI on PMPNews.com

HIBCC — Tue, 09 Oct 2012 20:22:36 +0000

An identification standards body speaks out on the draft regulation for medical devices.

Read Article →

The post Hankin Discusses UDI on PMPNews.com appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.

HIBCC Guideline: Understanding FDA’s Proposed UDI Requirement

HIBCC — Sat, 01 Sep 2012 23:48:34 +0000

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. The proposed rule by the Food and Drug Administration (FDA) will establish a UDI system that will require manufacturers to include both a plain-text version of the identifying data, and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear or two-dimensional bar codes, RFID tags, etc.

The post HIBCC Guideline: Understanding FDA’s Proposed UDI Requirement appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.

Updated Registered HIBC Labelers

HIBCC — Thu, 30 Aug 2012 02:00:49 +0000

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 HIBC uniform labeling system may apply for the assignment of one or more LICs.

Download Current HIBC Labelers

Download Current HIBC Dental Labelers

The post Updated Registered HIBC Labelers appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.

FDA Proposed UDI Regulation Released for Public Comment

HIBCC — Tue, 10 Jul 2012 01:45:06 +0000

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 section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices.

The post FDA Proposed UDI Regulation Released for Public Comment appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.

FDA Proposes Unique Device Identification

HIBCC — Tue, 03 Jul 2012 01:41:14 +0000

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 accurate reporting of adverse events.” The rule, published on July 10 in the Federal Register, also proposes an open database and standardized date formats for medical device labels. FDA is seeking comment on the proposal by November 7.

The post FDA Proposes Unique Device Identification appeared first on HIBCC - Welcome to the Health Industry Business Communications Council.