Draft Guidance for Device Industry and FDA - Postmarket Surveillance 2011

Key Topics

• Explain the legal background and overview of statutory criteria
• Review proposed changes
• Understand expectations for postmarket surveillance study duration
• Considerations regarding pediatric population provisions
• Why an order for postmarket surveillance will be issued under section 522?
• Describe the postmarket surveillance process and identification of issue
• Determine the elements to Include in a Postmarket Surveillance Study Plan
• Learn 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
• Understand 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Draft Guidance for Device Industry and FDA - Postmarket Surveillance brings together Clinical Affairs, Regulatory Affairs, Quality and Compliance, Investigators,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.