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!
Instructor Tips
FDA and Scope

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

Primer: US FDA Medical Device Regulations

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

FDA and Scope

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

Title 21 of the CFR

Medical Devices in the US
Learn what constitutes a medical device in the US, and is subject to FDA oversight

Medical Device Definitions

Exclusion and Exemptions

Substantial Equivalence

Substantial Equivalence

Product Classification

Product Classification Basics

Classification examples

513(g) vs Q-Submission

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

510(k) Submission

e-Star and 510(k)s

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

Premarket Approval (PMA)

Differences between 510(k) and PMA

De Novo Submission

De Novo sumbissions

Clearance vs Approval vs Granted

Basic Regulatory Strategy

Basic Regulatory Strategy

Facility Registration and Device Listing

Facility Registration

Device Listing

Quality Management and GMP
Brief introduction to quality management systems and Good Manufacturing Practices

Quality Management System

GMP and Exemptions

Final Updates and Timelines
Get the latest updates on FDA news and requirements

FDA Updates

Final Tools

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

FDA and Scope

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

Title 21 of the CFR

Medical Devices in the US Learn what constitutes a medical device in the US, and is subject to FDA oversight

Medical Device Definitions

Exclusion and Exemptions

Substantial Equivalence

Substantial Equivalence

Product Classification

Product Classification Basics

Classification examples

513(g) vs Q-Submission

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

510(k) Submission

e-Star and 510(k)s

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

Premarket Approval (PMA)

Differences between 510(k) and PMA

De Novo Submission

De Novo sumbissions

Clearance vs Approval vs Granted

Basic Regulatory Strategy

Basic Regulatory Strategy

Facility Registration and Device Listing

Facility Registration

Device Listing

Quality Management and GMP Brief introduction to quality management systems and Good Manufacturing Practices

Quality Management System

GMP and Exemptions

Final Updates and Timelines Get the latest updates on FDA news and requirements

FDA Updates

Final Tools

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

Medical Devices in the US
Learn what constitutes a medical device in the US, and is subject to FDA oversight

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

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

Quality Management and GMP
Brief introduction to quality management systems and Good Manufacturing Practices

Final Updates and Timelines
Get the latest updates on FDA news and requirements