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.
De Novo Classification Pathway
$49.00
- 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
