Loftware Invited to Feb. 12th FDA Workshop on Unique Device IDby Enterprise Labeling on Feb 9, 2009 • 3:26 pm No Comments
We’ve been invited to come to Washington this coming Thursday to attend and participate in the Food and Drug Administration’s (FDA) public workshop entitled: “Unique Device Identification System.” The purpose of the public workshop is to obtain information to help the FDA better understand the issues involved in the establishment of a unique device identification system (UDI system) and request comments on this topic.
For a complete overview of the agenda and topics to be discussed, see this link to a January 15th Notice in the Federal Register. If you plan to attend, or if you’re in the Washington area and wish to discuss medical device identifications systems, with an emphasis on GS1, please contact us (our Healthcare guru Chris Piela and myself will be in attendance). GS1 is certain to be a focal point of the Workshop, as this excerpt from the Notice suggests:
Current practices. Describe your current practices for applying standards to medical devices, marking identifiers on medical device labeling and managing medical device identifier data. For example, how do you currently use classification standards such as UNSPSC (United Nations Standard Products Service Code), nomenclature standards such as GMDN (Global Medical Device Nomenclature), and identification standards such as GS1 or HIBCC? What percent of your devices are not currently marked with a standardized identifier? Please describe any plans you have to change these practices in the near future.
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