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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 Compassionate Use?The FDA recognizes that there are circumstances in which an investigational de…Criteria for Compassionate Use1. The patient has a life-threatening or serious disease or condition; 2. T… See more

Expanded Access | Information for Industry | FDA

    https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry
    Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious ... Visit the medical device expanded access page to …

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

    https://www.fda.gov/news-events/public-health-focus/expanded-access
    For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or [email protected]. 2. After 4:30 p.m. …

Expanded Access | Information for Patients | FDA

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

Expanded Access | Information for Physicians | FDA

    https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians
    Drug, Biologic, and Medical Device expanded access (“compassionate use”) program data; Learning Resources. Expanded Access: Recourse for Patients Out of …

Emergency Use and Compassionate Use of …

    https://www.fda.gov/files/medical%20devices/published/Presentation--Institutional-Review-Board--Compassionate-and-Emergency-Use-%28PDF-Version%29.pdf
    Compassionate use of an unapproved device. unapproved device . z. Describe what is meant by compassionate use. z. The physician responsibilities with compassionate …

Emergency Use and Compassionate Use of …

    https://irb.ucsf.edu/emergency-use-and-compassionate-use-experimental-drugs-and-devices
    The emergency use provision in federal regulations allows physicians restricted access to investigational treatments that would be otherwise off-limits [21 CFR …

Compassionate use of drugs and medical devices in the …

    https://www.sciencedirect.com/science/article/pii/S2352320415000553
    The EU compassionate use programs are summarized in Table 2, , , .We investigated three EU countries – France, Germany and the UK. There is a common …

Investigational Medical Devices - Hopkins Medicine

    https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html
    The FDA regulations define items that are considered medical devices. A medical device is defined, in part, as any health care product that does not achieve its primary intended …

Expanded Access Programs for Medical Devices | RAPS

    https://www.raps.org/news-and-articles/news-articles/2018/4/expanded-access-programs-for-medical-devices
    However, medical device compassionate use programs may be coordinated and implemented by EU Member States (MS) according to national rules and …



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