Custom Devices: Improving Patient Quality of Life and Clinician Capabilities

Posted 19 November 2015 By Carol Vierling

placeholder+image This article discusses the definition of a custom device, how a custom device is developed and regulations to be followed to place a custom device on the market. The article also discusses when a compassionate use request may be appropriate.

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Categories: Medical Devices, Compliance, Features, US, CDRH

Tags: Custom Medical Devices, Custom Device Exemption, FDASIA, Patient-Specific Devices, Compassionate Use

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