Course Description

US FDA Investigational Device Exemption (IDE) Overview

Course Description:

According to the risk factor surrounding any investigational device, an investigational device exemption (IDE) is required by the FDA in order to allow the investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data in support of a PMA application and in some cases, a 510(k) submission.
Sounds simple enough – let’s do it. So where do we start?
This 4 part course by US regulatory expert Carole Stamp outlines FDA regulations related to US clinical studies for medical devices and will provide you with a comprehensible and clear look at the IDE application process, differentiating significant and non-significant risk studies, addressing typical problems that can arise during studies as well as an overview of FDA inspection procedures and requirements.


Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Comprehend FDA regulations related to US clinical studies for medical devices and the IDE process.
  • Recognize the differences and implications involved with significant and non-significant risk studies.
  • Identify and address typical problems during clinical studies that can have a direct affect an IDE.
  • Define FDA inspection procedures and requirements relevant to IDE approval.

Who Should Enroll:

Any professional who is part of an IDE study team.


Prerequisite Knowledge/Requirements:

None


Subject Matter Expert:
Carole Stamp

Duration:
125 min

Release date:
07/09/2010

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 381.00
Premium Account: € 286.00

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