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De Novo Classification Pathway

$49.00

This Meditrial Video Course is designed to help you discover the FDA De Novo Classification Pathway and intended to provide De Novo requesters with transparency regarding the process of submission De Novo Classification request.

Description

Why take this course

This Meditrial Video Course is designed to help you discover the FDA De Novo Classification Pathway and intended to provide De Novo requesters with transparency regarding the process of submission De Novo Classification request.

What I will learn

This course will highlight each and every aspect you need to learn regarding the De Novo Classification Pathway and understand all the steps involved in the application in order to achieve a successful De Novo Classification Request.

Skills I will gain

  • Learn what is a De Novo Classification Pathway request
  • Identify the types of information FDA believes are necessary to conduct a substantive review for a De Novo request
  • Explore the procedures and criteria FDA intends to use in assessing whether a De Novo request for an evaluation of the new device classification meets a minimum threshold of acceptability
  • Understand the timelines and applicable user fees for the application for the De Novo Classification request

 

TOPICS

  • Introduction (00:01:19)
  • What is a De Novo Classification (00:00:56)
  • What is a De Novo Classification Request? (00:01:06)
  • What is Regulatory Controls? (00:01:21)
  • De Novo Request Pre-Submission (00:00:50)
  • FDA Review (00:00:45)
  • The FDA De Novo Classification Process (00:01:47)
  • The De Novo Request Timeline and User Fees? (00:01:22)
  • De Novo Request Decision (00:01:16)
  • How to Prepare a De Novo Request (00:04:53)
  • How to Submit a De Novo Request (00:02:53)
  • Case Studies (00:02:56)

  • Final Test
  • Certification

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