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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 Learn more at: http://www.wmdo.org/course-detail.asp...