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.

Areas Covered in the Seminar:

• Review proposed changes
• Explain the legal background and overview of statutory criteria.
• Considerations regarding pediatric population provisions.
• Understand expectations for postmarket surveillance study duration.
• Describe the postmarket surveillance process and identification of issue.
• Why an order for postmarket surveillance will be issued under section 522?
• Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved?
• Determine the elements to Include in a Postmarket Surveillance Study Plan.