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.