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INVESTIGATIONAL DEVICE EXEMPTION (IDE)

$79.00

In this training, you will learn what IDE means, and how to prepare and submit your application to the FDA.

Description

Welcome to the Investigational Device Exemption or IDE training. In this training, you will learn what IDE means, and how to prepare and submit your application to the FDA.

After the course, you can take a brief test to receive the certification. Enjoy!

 

TOPICS

  • What is an investigational device exemption (IDE)? (00:04:11)
  • Significant and Nonsignificant Risk Devices (00:16:23)
  • IDE Exempt Investigations (00:02:07)
  • IDE Applications (00:11:32)
  • FDA Action on IDE Applications (00:04:05)
  • IDE Reports (00:06:08)
  • IDE Institutional Review Boards – IRB (00:03:16)

  • Final Test
  • Course evaluation survey
  • Certification

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