Course Description

US FDA 510(k) Notification Process

Course Description:

This course provides a fundamental and expansive overview of the US FDA 510(k) Notification Process and how it works.

It covers the following topics:

  • How the FDA defines and classifies medical devices using the FDA review and clearance process
  • The preparation of a traditional 510(k) notification
  • Examples of how and when to submit a new 510(k) for device modifications made during the post-market phase
  • Direct links to FDA guidance documents, FDA forms, and various databases for classifications, predicate devices, and recognized standards
  • Interactive multi-scenario case studies
  • Audio and video presentations
  • Glossary items
  • Detailed charts
  • Models and graphics

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Formulate what constitutes a medical device according to FDA definitions
  • Determine and classify medical devices according to recognized FDA standards
  • Prepare a basic 510(k) notification submission
  • Explain and identify the FDA review and clearance process
  • Identify post-market changes that may prompt the need for a new 510(k)

Who Should Enroll:

Regulatory or quality professionals who wish to understand the US FDA 510(k) Notification Process are encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

WMDO course Overview of US FDA Quality System Regulation is recommended but not required.

Subject Matter Expert:

50 min

Related resources:

Case studies:

Basic Account: € 152.00
Premium Account: € 114.00

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