Now Available -- Updated HL7 SPL Implementation Specification Files

Dear GUDID Email Subscribers,

 

The GUDID HL7 SPL Implementation Files have been updated and are presently available at-- http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm#hl7spl

 

The updated files include updates that will be made for GUDID Release 1.2.1. These updates are scheduled to be pushed as follows –

  • GUDID pre-production environment by end of April 2014
  • GUDID production environment by beginning of May 2014   
  • The ReadMeFirst file, changelog tab, contains complete details of the updates. They include the following --    
    • Addition of a new Production Identifier: Donation Identification Number (DIN) –indicates the device is managed by a DIN.  This number can be found on the device label or packaging.  The DIN is applicable to devices that are also regulated as Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/Ps) and is a number that is assigned to each donation; required attribute; must answer Yes/No
    • Changes to MRI Safety Status: The existing two questions have been combined into one question which reads “What MRI safety information does the labeling contain?” The list of values will include: MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.
    • New additions to the list of values for Sterilization Method: Nitrogen Dioxide, Supercritical Carbon Dioxide, High Level Disinfectant and Liquid Chemical Sterilant
    • Changes to list of values for Size Type and Unit of Measure -- Weight, Pressure, Pore Size, Area/Surface Area, and Angle will be added; Second Greatest Diameter and Third Greatest Diameter will be removed; related Units of Measure will be added.

For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.

Sincerely,
FDA UDI Team 

o   Changes to MRI Safety Status: The existing two questions have been combined into one question which reads “What MRI safety information does the labeling contain?” The list of values will include: MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.

o   Changes to MRI Safety Status: The existing two questions have been combined into one question which reads “What MRI safety information does the labeling contain?” The list of values will include: MR Safe, MR Unsafe, MR Conditional and Labeling does not contain MRI Safety Information.


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