De Novo Classification Pathway


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.

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

Course Breakdown

Section Time
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

Exam and Certifications

  • Final Test
  • Certification


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
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