Course Description

Introduction to the US FDA

Course Description:

This course examines the range of the US FDA’s responsibilities and provides a chronological history of significant events regarding the US FDA and medical devices. It lays the foundation by exploring the regulations found in 21 Code of Federal Regulations (CFR) and the various pathways of marketing medical devices in the US.

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Learning Objectives:

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

  • Gain a better understanding of the definition of the US FDA
  • Grasp the US FDA’s current responsibilities within the medical device industry
  • Recognize the history of the US FDA as it relates to the current regulation of medical devices

Who Should Enroll:

All professionals who wish to know more about the US FDA’s approach to medical devices are welcome 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:

25 min

Related resources:

Case studies:

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