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Draft Guidance for Device Industry and FDA - Postmarket Surveillance brings together Clinical Affairs, Regulatory Affairs, Quality and Compliance, Investigators,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.
