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If this human subjects study involves the use of any devices, the study is subject to Food and Drug Administration (FDA) regulations. Researchers planning to use devices in human subjects research must complete this form and include it with an original New Protocol Application or a Protocol Amendment Form, as applicable.
- The word "experimental" must appear in the consent form as a modifier to the device name.
- Documentation of FDA approval for the experimental use of these agents or devices must be provided.