What is the FDA’s policy regarding charging for investigational medical devices and radiological health products?


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.

About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory and Quality Assurance

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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