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IDE Functions
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TRACE32 Documents ......................................................................................................................PRACTICE
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What is ide functions?
IDE functions stands for Investigational Device Exemption functions. It is a premarket approval application that allows a device to be used in clinical trials.
Who is required to file ide functions?
Manufacturers or sponsors of medical devices conducting clinical trials are required to file IDE functions.
How to fill out ide functions?
IDE functions are typically filled out electronically through the FDA's online submission portal.
What is the purpose of ide functions?
The purpose of IDE functions is to ensure the safety and effectiveness of medical devices by allowing them to be used in clinical trials under FDA supervision.
What information must be reported on ide functions?
IDE functions must include information about the device, the clinical trial protocol, the investigators, and the monitoring and reporting of adverse events.
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