An investigational device exemption (IDE) is required for a device that will be used in clinical trials to support a PMA submission. IDE's are also required for clinical evaluation of certain modifications to or new intended uses of legally marketed devices. An IDE may be granted by the Institutional Review Board (IRB) at the facility where the investigational study will take place. The FDA must also approve the IDE if significant risk is involved.
The CDRH section "Device Advice'' of the FDA's Web site provides extensive detail and guidance on the device submission and approval process. [4. http://www.fda.gov/cdrh/ devadvice/ (accessed October 2005).]
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