A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.
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Humanitarian Use Device
Published by IRDiRC
Regulatory AffairsEarly Access SupportMedical DeviceHumanitarian Use DeviceSafe Medical Devices Actthe Safe Medical Devices Act to create a new regulatory pathway for device products intended for diseases or condition that affect small (rare) populations that defined HDEs and HUDs.
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Conditional Early Approval System for Medical Devices
Published by IRDiRC
Regulatory AffairsEarly Access SupportMedical DeviceMHLW or PMDA RegulatoryPMDAConditional Early Approval SystemCEASDConditional Early Approval System is a system to put highly useful and effective medical devices for treating serious diseases into practical use as early as possible.
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