Medical Devices 2011 - Draft Guidance for Device Industry and FDA - Postmarket Surveillance

This webinar will cover FDA's Draft Guidance on Post market Surveillance Studies for device manufacturers Under Section 522. It will help you understand the proposed changes and agency expectations regarding different stages of Post market Surveillance Studies.

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the 510(K), PMA, HDE or PDP process.

This webinar will provide an overview and guidance to firms that are either going through or preparing to do postmarket surveillance activities. The training will cover expectations for Postmarket Surveillance Studies, the surveillance process, elements to include in a Postmarket Surveillance Study plan and expectations for different stages of Postmarket Surveillance Study Reports.