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Expanded Access for Medical Devices | FDA

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

    Frequently Asked Questions About Medical Devices | FDA

      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices
      This document supersedes Medical Devices, Frequently Asked Questions about IRB Review of Medical Devices, and Emergency Use of Unapproved Medical Devices …

    Frequently Asked Questions About Medical Devices

      https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf
      In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a …

    FDA warns public not to use unapproved or uncleared …

      https://www.fda.gov/news-events/press-announcements/fda-warns-public-not-use-unapproved-or-uncleared-medical-devices-help-assess-or-diagnose-concussion
      Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head …



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