Primer: US FDA Medical Device Regulations

About Course

A practical course discussing the medical device requirements in the USA.

The United States represents a sought after medical device market, and is a central part of any global product launch. The US FDA is a unique regulator, with specific requirements, pathways and hurdles to navigate unlike any other market in the world. This course focuses on the practical FDA submission process, using real-world examples and exercises to help you understand and implement the most time and cost efficient route to the US market.

Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to sell their devices in the USA.

We are currently revising this course. The updated version is expected in October 2024.

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Course Content

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

Welcome!

00:54
Instructor Tips

01:37

Code of Federal Regulations
Understand the legal basis for medical device regulation in the US

About Course

What Will You Learn?

Course Content

Introduction and Background Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

Welcome!

Instructor Tips

Code of Federal Regulations Understand the legal basis for medical device regulation in the US

FDA and Scope

Title 21 of the CFR

Device Classification Learn how devices are defined and classified in the US, and the tools we can use to determine classification of our device

Medical Device Definitions

Device Classification

Device Classification: Answers

FDA Regulatory Pathway

FDA Regulatory Pathway

510(k) Submissions Let's explore the most commonly used FDA submission: the 510(k)

Basic Overview 510(k) Process

Concept of Substantial Equivalence

Intended Use vs Indications for Use

Identifying a Predicate

Substantial Equivalence Workflow

Types of 510(k)s

510(k) structure

513(g) Mechanism Learn about the handy 513(g) mechanism: when and how to use it

513(g) Mechanism

De Novo Submission

De Novo sumbissions

De Novo Strategy

Premarket Approval (PMA) High-risk devices require a more sttingent submission, the PMA. Let's find out more.

Premarket Approval (PMA)

FDA Cleared vs FDA Approved

Quality System Requirements Brief introduction to quality management systems and Good Manufacturing Practices

FDA QSR

Submission Process and Costs

Submission Process and Costs

Post-Submission Get the latest updates on FDA news and requirements

Post-Submission Process

Device and Registration Listing

Emergency Use Authorizations

Emergency Use Authorizations

Final Tools

Final Tools and Resources

Student Ratings & Reviews

Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.

Code of Federal Regulations
Understand the legal basis for medical device regulation in the US

Device Classification
Learn how devices are defined and classified in the US, and the tools we can use to determine classification of our device

510(k) Submissions
Let's explore the most commonly used FDA submission: the 510(k)

513(g) Mechanism
Learn about the handy 513(g) mechanism: when and how to use it

Premarket Approval (PMA)
High-risk devices require a more sttingent submission, the PMA. Let's find out more.

Quality System Requirements
Brief introduction to quality management systems and Good Manufacturing Practices

Post-Submission
Get the latest updates on FDA news and requirements