FREQUENTLY Asked Questions

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

View All FAQs
About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

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.

Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST