Table 1
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Summary of main criteria for priority regulatory review processes for devices in use in some countries

  • Priority review is limited to specific innovations addressing unmet medical needs:

    • They treat a life-threatening or severely debilitating disease for which there is no authorized treatment, or which causes high morbidity or mortality, despite existing treatments

    • They are first-in-class technologies, or they represent a breakthrough, or they offer a significant improvement compared to approved alternatives

    • The benefit of the innovation’s immediate availability to patients is considered greater than the risk inherent in requiring additional data

  • Priority review is limited to specific innovations addressing unmet medical needs:

    • They treat a life-threatening or severely debilitating disease for which there is no authorized treatment, or which causes high morbidity or mortality, despite existing treatments

    • They are first-in-class technologies, or they represent a breakthrough, or they offer a significant improvement compared to approved alternatives

    • The benefit of the innovation’s immediate availability to patients is considered greater than the risk inherent in requiring additional data

Based on references.7–11

Table 1
Open in new tab

Summary of main criteria for priority regulatory review processes for devices in use in some countries

  • Priority review is limited to specific innovations addressing unmet medical needs:

    • They treat a life-threatening or severely debilitating disease for which there is no authorized treatment, or which causes high morbidity or mortality, despite existing treatments

    • They are first-in-class technologies, or they represent a breakthrough, or they offer a significant improvement compared to approved alternatives

    • The benefit of the innovation’s immediate availability to patients is considered greater than the risk inherent in requiring additional data

  • Priority review is limited to specific innovations addressing unmet medical needs:

    • They treat a life-threatening or severely debilitating disease for which there is no authorized treatment, or which causes high morbidity or mortality, despite existing treatments

    • They are first-in-class technologies, or they represent a breakthrough, or they offer a significant improvement compared to approved alternatives

    • The benefit of the innovation’s immediate availability to patients is considered greater than the risk inherent in requiring additional data

Based on references.7–11

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