Medical Devices: US Regulations

This course is intended to provide a basic overview of US medical device regulation.

This course is intended to provide a basic overview of US medical device regulation. It covers a wide range of topics issues, from the history of medical device regulation to the steps required to submit an application to the US Food and Drug Administration (FDA) for approval (or clearance), and to market a device that adheres to postmarket requirements.

This course also discusses device classification as well as how to select the appropriate FDA application for the device and other general device controls, including labeling, establishment registration and device listing, quality system regulation, and adverse event and reporting as well as and device corrections and removals reporting.

At a Glance

Target Audience: This course is intended for new regulatory professionals and those in related departments interested in understanding the basics of US medical device regulation.

Learning Level: Basic

Total Length of Course: 5 Hours

RAC Points: 5

Medical Device Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Define a medical device and understand the FDA regulations surrounding the commercialization of a medical device

Understand interactions among groups within FDA, with other US government agencies and with device manufacturers

Understand the Quality System Regulation (21 CFR 820) and how it governs manufacturing

Describe device submissions, their requirements and uses and how to select the most appropriate type

Describe and explain the regulation of advertising, promotion and labeling

Understand postmarket requirements, including those sometimes imposed by FDA as a condition of marketing approval