• Online, Self-Paced

Gain insights into the U.S. regulatory framework for medical devices with "FDA Class I, II, III Regulations (USA) Fundamentals." Understand classification requirements, approval processes, and compliance strategies for bringing medical devices to market.

Learning Objectives

  • Understand the FDA classification system for medical devices.
  • Analyze the regulatory requirements for Class I, II, and III devices.
  • Evaluate the premarket submission pathways for different device classifications.
  • Identify the postmarket surveillance requirements for medical devices.
  • Discuss the key differences between the regulatory pathways for each device class.

Framework Connections

The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):