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21CFR Part 812.35GENERAL INSTRUCTIONS AMENDMENTS AND SUPPLEMENTS WHAT IS THE DIFFERENCE BETWEEN AMENDMENT AND SUPPLEMENT? Amendment An IDE amendment is any additional submissions to an IDE before

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What is 21cfr part 812?

21 CFR Part 812 is a regulation established by the FDA that governs the use of investigational devices in clinical trials. It outlines the requirements for conducting studies involving medical devices to ensure their safety and effectiveness.

Who is required to file 21cfr part 812?

Sponsors of investigational device studies are required to file 21 CFR Part 812. This includes individuals or organizations that initiate and are responsible for the investigation of an investigational device.

How to fill out 21cfr part 812?

To fill out 21 CFR Part 812, sponsors must prepare an Investigational Device Exemption (IDE) application that includes information on the device, study protocols, informed consent documents, and plans for monitoring the study.

What is the purpose of 21cfr part 812?

The purpose of 21 CFR Part 812 is to protect the rights and welfare of human subjects involved in clinical studies and to ensure that the studies are conducted under proper scientific and ethical standards.

What information must be reported on 21cfr part 812?

Information that must be reported includes details about the investigational device, the study protocol, the study population, informed consent processes, and safety monitoring plans.

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