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Postmarket Surveillance Studies

• Introduction
• References and Contact Information (Updated Nov 2008)
• Guidances and Reports

Post Approval Studies

• Post Approval Studies Status
• Guidance Documents
• Contact Information

Related Information

• Hospital Bed Safety
• Human Factors & Postmarket Surveillance at FDA
• Postmarket Surveillance of Cardiovascular Devices [PDF]
• Medical Device Reporting
• Patient Safety News
• Safety Issues and Alerts
• LASIK
• Liposuction

Adverse Events

• General Information on Adverse Event Reporting Files

MedSun

• Designing a Medical Device Surveillance Network (PDF)
• Final Report of Feasibility Study
• MedSun: Medical Product Safety Network

Resources

• Guidance and Reports
• Presentations
• Consumer Questions on Adverse Events