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Expanded Access for Medical Devices | FDA

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices
    What is a Treatment IDE?An approved IDE specifies the maximum number of clinical sites and the maxi…Criteria for a Treatment IDE1. The device is intended to treat or diagnose a serious or immediately li… See more

Health Canada's special access programs: Request …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices.html
    Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their …

Expanded Access | FDA - U.S. Food and Drug …

    https://www.fda.gov/news-events/public-health-focus/expanded-access
    Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to …

Health Canada's special access programs: Overview

    https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access.html
    Through Health Canada's special access programs (SAP), health care professionals may access non-marketed drugs and medical devices not yet authorized for sale in …



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