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FDA Class I, II, III Regulations (USA) Fundamentals
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.
Course Overview
None
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):
Competency Areas
Work Roles
Feedback
If you would like to provide feedback on this course, please e-mail the NICCS team at NICCS@mail.cisa.dhs.gov. Please keep in mind that NICCS does not own this course or accept payment for course entry. If you have questions related to the details of this course, such as cost, prerequisites, how to register, etc., please contact the course training provider directly. You can find course training provider contact information by following the link that says “Visit course page for more information...” on this page.