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Emmitsburg NEWSJOURNAL VOLUME 14, NO. 8ex alting the importance of ide a s and information Edward R . MurrowM Y FA I R F I E L D . N E T NEWS Emmitsburg Prepares For Town Elections Two Commissioner

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What is an IDE?

An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.

Who is required to file an IDE?

The sponsor (usually the device manufacturer) is required to file an IDE.

How to fill out an IDE?

The sponsor must submit an IDE application to the FDA, which includes detailed information about the device, the study protocol, and plans for monitoring and reporting.

What is the purpose of an IDE?

The purpose of an IDE is to ensure the protection of human subjects participating in clinical studies involving investigational devices, as well as to collect data on the safety and effectiveness of the device.

What information must be reported on an IDE?

The IDE application must include information on the device, study protocol, patient selection criteria, monitoring plans, and plans for handling and reporting adverse events.

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