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FDA Premarket Approval (PMA)

$79.00

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

Description

Why take this course

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

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

 

TOPICS

  • 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)

  • Final Test
  • Certification

Additional information

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