Course Description

US FDA Investigational Device Exemption (IDE) Overview

Course Description:

This four-part course, created by US regulatory expert Carole Stamp, outlines the FDA regulations concerning US clinical studies for medical devices. It provides a comprehensive and clear look at the Investigational Device Exemption (IDE) application process, significant and non-significant risk studies, common problems that can arise during studies, and an overview of FDA inspection procedures and requirements.

Based on certain risk factors surrounding investigational devices, IDEs are now required by the FDA in order for investigational devices to be used in the following circumstances:

  • Procuring clinical studies
  • Collecting safety and effectiveness data in support of PMA applications
  • Writing 510(k) submissions (applicable only in certain cases)

Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Comprehend the FDA regulations concerning US clinical studies for both medical devices and the IDE process
  • Recognize the differences and implications involved in both significant and non-significant risk studies
  • Identify and address common problems that can occur during clinical studies and that can directly affect IDEs
  • Define FDA inspection procedures and requirements relevant to the IDE approval process

Who Should Enroll:

Professionals who participate in IDE study teams are encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; all areas of expertise are welcome.

Subject Matter Expert:

125 min

Related resources:

Case studies:

Basic Account: € 381.00
Premium Account: € 286.00

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