IIRF Online > Business > Industry > Medical Device Development > Practical Regulatory Affairs 2020 - US FDA Medical Devices
Practical Regulatory Affairs 2020 - US FDA Medical Devices by Udemy
A practical course discussing the US FDA Medical Device regulations for real-world situations
Course Highlights
- Learn about US regulations for medical devices, and the role of the FDA
- Understand the various regulatory pathways available for medical devices in the US
- Learn how to practically use the various FDA tools and databases to determine the required regulatory route
- Discover how to navigate the FDA website to find more relevant information for specific devices
Skills you will learn!
Curriculum
1 Topic
Introduction
4 Topics
The Food and Drug Administration
Code Of Federal Regulations
Title 21 CFR Quiz
Medical Device Definition and Scope
3 Topics
Device Classification Basics
Device Classification Examples and Excercise
Device Classification Exercise Answers
1 Topic
Regulatory Pathways
6 Topics
Basic Overview of the 510(k) Process
Concept of Substantial Equivalence
Intended Use vs Indications for Use
Identifying a Predicate Device
Substantial Equivalence Workflow
510(k) Structure
1 Topic
513(g) Mechanism
2 Topics
Overview of De Novo Submission
Basic De Novo Strategy
2 Topics
PMA Submissions
FDA Cleared vs FDA Approved
4 Topics
FDA QSR
Submission Costs
Post Submission Process and Timelines
Device Registration and Listing
1 Topic
Basic EUA Overview
1 Topic
Final Tools
Practical Regulatory Affairs 2020 - US FDA Medical Devices
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