Medical Devices: US Regulations

This course is intended to provide a basic overview of US medical device regulation. It covers a wide range of 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) 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 listing, quality system regulations, adverse event and correction and removal reporting.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

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: 5–10 Hours
  • RAC Credits: 5
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $535; List $735
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Learning Objectives

Upon completion of this course, participants should be able to:

  • Define a medical device and understand the FDA regulations surrounding commercialization of a medical device
  • Understand interactions among groups within FDA, with other US government agencies and with device manufacturers
  • Describe types of device submissions, their requirements and uses and how to select the most appropriate one
  • Describe and explain the regulation of advertising, promotion and labeling
  • Understand postmarketing requirements, including those sometimes imposed by FDA, as a condition of marketing approval

Lesson Titles

  • Lesson 1: Background and History of FDA Regulations
  • Lesson 2: Device Development, Quality Systems and Agency Interactions
  • Lesson 3: Marketing Submissions
  • Lesson 4: Advertising, Labeling, and Promotion
  • Lesson 5: Postmarket Activities

Registration Options

This course is available for purchase as follows: