FDA Finalizes Unique Device Identifier Rule

Franken, Jessica
November 2013
Nonwovens Industry;Nov2013, Vol. 44 Issue 11, p38
The articel discusses the final rule released by the U.S. Food and Drug Administration (FDA) that requires most medical devices distributed in the U.S. to carry a unique device identifier (UDI). The author mentions that UDIs must be carried on the labels and packaging of high-risk medical devices, such as pacemakers, defibrillators, and heart pumps. She also tackles the advancement of chemical safety reform measures to several countries including South Korea, Taiwan and India.


Related Articles

  • FDA clears plant restrictions at Boston Scientific's St. Paul facility.  // Cardiovascular Device Update;May2007, Vol. 13 Issue 5, p16 

    The article reports on the decision of the U.S. Food and Drug Administration (FDA) to lift restrictions from a warning letter it issued to Boston Scientific after the re-inspection of one of its plants that makes cardiac rhythm management devices in Saint Paul, Minnesota. FDA found that the...

  • Medtronic's left-heart lead gets FDA OK. McNulty, Mike // Rubber & Plastics News;9/20/2004, Vol. 34 Issue 4, p7 

    This article reports that Medtronic Inc., has received U.S. Food and Drug Administration approval for its Attain 4194 Bipolar over-the-wire left-heart lead that uses a silicone tip seal. It's the fourth generation of left-heart leads — which are thin, insulated wires that connect an...

  • Devices That Keep the Heart Beating Search Consumer Updates.  // Biomedical Market Newsletter;3/7/2011, p405 

    The article offers information on different types of heart devices and approval of the U.S. Food & Drug Administration (FDA). It states that heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. It mentions that FDA has new type...

  • CT energy may interact with devices.  // Medical Device Daily;7/15/2008, Vol. 12 Issue 135, p3 

    The article reports on a public safety statement published by the U.S. Food and Drug Administration on July 14, 2008 which stated that some pacemakers, defibrillators, neurostimulators and infusion pumps may present hazard when exposed to X-rays during computed tomography (CT) imaging sessions...

  • Medtronic spreads word about Vision 3D at Heart Rhythm '08. Pedersen, Amanda // Medical Device Daily;5/20/2008, Vol. 12 Issue 97, p1 

    The article talks about the U.S. Food and Drug Administration (FDA) approval won by Medtronic for its Vision 3D portfolio of heart rhythm products in April 2008. The approval was announced by Medtronic during the 2008 scientific sessions of the Heart Rhythm Society. Some of the devices included...

  • More trouble for Guidant.  // Dow Theory Forecasts;1/2/2006, Vol. 62 Issue 1, p1 

    The article reports that Guidant Corp. has received a warning letter from the U.S. Food and Drug Administration (FDA) about unresolved quality-control and maintenance problems discovered by the agency during an inspection of a pacemaker plant completed in September 2005. According to Guidant, it...

  • AEDs recalled.  // Fire Engineering;Sep2006, Vol. 159 Issue 9, p46 

    The article reports on the recall of the 1,184 automated external defibrillators (AED) manufactured by MRI Inc. from February 2002 to October 2004 in the U.S. Food and Drug Administration's MedWatch has given alert to AED's electrical contact problem which maybe due to its failure to produce a...

  • FDA study evaluates rising ICD malfunction trend.  // Materials Management in Health Care;Oct2005, Vol. 14 Issue 10, p8 

    Evaluates the implantable cardioverter defibrillators (ICD) malfunction trend in the U.S., by the Food and Drug Administration. Basis in the study of the ICD; Decrease rate replacements due to malfunctions; Citations of the overall malfunctions of ICD and pacemakers.

  • NATIONAL DEVICE LIST PART OF REFORM BILL.  // Materials Management in Health Care;Nov2009, Vol. 18 Issue 11, p5 

    The article reports that the national health care reform proposals require a comprehensive medical-device registry to uncover safety problems. It states that the registry could be used in tracking down patients in case implants, surgical tools, and supplies will be recalled. It adds that only 14...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics