Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: US Regulations [5.0 RAC]

5.0 RAC Credits Member: $545.00 Nonmember: $745.00
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Medical Devices: US Regulations [5.0 RAC]
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

Learning Objectives

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

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

Enrollment Period: 12 months
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