The Investigational Device Exemption (IDE) regulations allow sponsors to charge for an investigational device. However, the charge should not exceed an amount necessary to recover the costs of manufacture, research, development, and handling of the investigational device. A sponsor justifies the proposed charges for the device in the IDE application, states the amount to be charged, and explains why the charge does not constitute commercialization. FDA generally allows sponsors to charge investigators for investigational devices, and this cost usually is passed on to the subjects.

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