Lesson 5

Overview of Regulatory Systems and Agencies in the US

This lesson focuses on the history and development of healthcare product regulation within the US. It briefly outlines the responsibilities of various centers within the Food and Drug Administration, the regulatory mechanisms and processes used and interactions with other US agencies.

Lesson Objectives
At the completion of this lesson, you will be able to:

• Describe the origins of the US regulatory system and how they set the stage for today
• Identify the organizations involved in the US regulatory system and how they are organized
• Match the FDA's centers and offices to the products for which they have responsibility
• Distinguish between regulations and guidances
• Outline how the regulatory processes work
• Identify resources for additional information

Lesson Outline
These are the topics covered in Lesson 5. You may go directly to any of the topics using the pulldown box in the navigation bar on the left.