The Approval Process for New Medical Devices

This course provides an overall view of the development regulatory process for legally marketing a new medical device in the US. Topics in this course include: Classification, Approval Process, IDE, Clinical Studies, and PMA. After completing this course, learners will be able to identify the major steps in new device development and the required regulatory process for the US market. Learners will also recognize the purpose and requirements of clinical studies. Learners will be able to identify the elements of a 510(k), an IDE, and a PMA. Finally, learners will recognize key information about the classification of medical devices and the role of FDA in the approval of medical devices for the US marketplace.

After this course learners will be able to identify the major steps in new device development. identify the required regulatory process for the us market. identify the purpose and requirements of clinical studies. identify the elements of a 510(k), an ide, and a pma. recognize key information about the classification of medical devices. recognize the role of fda in the approval of medical devices for the us marketplace.