Medical Device Filings: 510(k), PMA, and IDE

This course describes the premarket approval and notification processes for medical devices in the US. Topics in this course include: FDA Authority, Classification, Premarket Notification, Premarket Approval, IDE, and Compliance. After completing this course, learners will be able to identify the essential elements of the 510(k), premarket approval (PMA), and Investigational Device Exemption (IDE) filing processes for medical devices under FDA.

After this course learners will be able to identify the essential elements of the 510(k), premarket approval (pma), and investigational device exemption (ide) filing processes for medical devices under fda.