FDA Premarket Approval (PMA)


In the Premarket Approval course we will provide regulatory information on the Premarket Approval process.

  • Course Type: Video Lessons
  • Language: English
  • Level: Intermediate
  • Session: year 2021
  • Time: 0 - 1 Hour
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Course Breakdown

Section Time
Introduction 00:00:36
Regulatory Information 00:03:08
Review Process 00:09:46
Application Methods 00:03:10
Application Contents 00:06:21
Post Approval Requirements 00:07:00
Supplements and Amendments 00:09:44
PMA Special Considerations 00:09:14

Exam and Certifications

  • Final Test
  • Certification


What I will learn?

This course will highlight each and every aspect you need to learn regarding Premarket Approval process and the necessary application methods and requirements. You will also explore the steps for PMA supplements and amendments.

Skills I will gain

  • Discover Premarket Approval process
  • Explore the PMA application methods and content
  • Learn key procedures for the review process and post approval requirements
  • Understand the PMA supplements and amendments as well as other special considerations


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