Draft Guidance for Device Industry and FDA - Postmarket Surveillance - Webinar By GlobalCompliancePanel 2011

Key Topics

• The legal background and overview of statutory criteria
• Review proposed changes
• Expectations for postmarket surveillance study duration
• Considerations regarding pediatric population provisions
• Why an order for postmarket surveillance will issued under section 522
• The postmarket surveillance process and identification of issue
• The elements to Include in a Postmarket Surveillance Study Plan
• Why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved
• Current expectations for different stages of Postmarket Surveillance Study Reports
• Why FDA may order postmarket surveillance to address a wide variety of device-related public health questions
• Why happens if you fail to complete a Postmarket Surveillance Study

Draft Guidance for Device Industry and FDA - Postmarket Surveillance brings together Clinical Affairs, Regulatory Affairs, Quality and Compliance, Investigators, Distributors/Authorized Representatives, Marketing & Sales, Consultants and Legal Counsel.