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IDE Definitions and Acronyms | FDA

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-definitions-and-acronyms
    Investigational device is a device, including a transitional device, that is the …

Investigational Devices - Human Research Protection …

    https://irb.ucsf.edu/investigational-devices

    IDE Responsibilities | FDA

      https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities
      Under §812.5 an investigational device or its immediate package must bear a label with the following information: the name and place of business of the …

    Investigational Device Exemption (IDE) | FDA

      https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
      An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical …

    Investigational Medical Devices | Research - University …

      https://research.virginia.edu/irb-hsr/investigational-medical-devices
      An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a …

    eCFR :: 21 CFR Part 812 -- Investigational Device …

      https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812
      ( g) Investigational device means a device, including a transitional device, that is the object of an investigation. ( h) Investigation means a clinical investigation or research involving …

    FAQs about Investigational Device Exemption | FDA

      https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption
      Under § 812.5 an investigational device or its immediate package must bear a label with the following information: the name and place of business of the manufacturer, packer, or …

    Investigational Medical Devices | Research - University …

      https://research.virginia.edu/irb-hsr/investigational-medical-devices-0
      Investigational device means a device, including a transitional device, that is the object of an investigation. A medical device is considered investigational if either condition …

    GUIDELINES ON MEDICAL DEVICES CLINICAL …

      https://ec.europa.eu/docsroom/documents/16477/attachments/1/translations/en/renditions/pdf
      Investigational medical device Medical device being assessed for safety or performance in a clinical investigation NOTE: This includes medical devices already on the market that …



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