2015May core #876 - GMDN FDA guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Medium
    • FHIR Core (FHIR)
    • DSTU1 [deprecated]
    • Devices
    • DeviceMetric
    • Hide

      We agree that requiring IEEE is too restrictive, however requiring GMDN is equally restrictive and is impossible to comply to in other domains and realms.

      So we will change the binding strength of this element from "required" to "preferred" to enable the use of alternative coding systems.

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      We agree that requiring IEEE is too restrictive, however requiring GMDN is equally restrictive and is impossible to comply to in other domains and realms. So we will change the binding strength of this element from "required" to "preferred" to enable the use of alternative coding systems.
    • Chris Courville / Stefan Schlichting: 17-0-1
    • Correction
    • Non-compatible
    • DSTU1 [deprecated]

      Existing Wording: DeviceMetric.type Describes the metric type Required RTM Management Service

      DeviceMetric.unit Describes the unit of the metric Required RTM Management Service

      Proposed Wording: DeviceMetric.type Describes the metric type Required GMDN

      DeviceMetric.unit Describes the unit of the metric Required UCUM…"

      Comment:

      GMDN is the only device type nomenclature supported by the FDA Global UDI Database so it does make sense to constrain the resource to IEEE as specified in RTMMS. It would also be preferable to reference IEEE as the source of coding system somehow. RTMSS is just a publisher of said codes not a coding system.

            Assignee:
            Unassigned
            Reporter:
            Ioana Singureanu
            Watchers:
            3 Start watching this issue

              Created:
              Updated:
              Resolved: