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Summary

Surveillance Reports document your systematic analysis of device safety and performance throughout the post-market lifecycle through comprehensive evidence evaluation. You demonstrate ongoing compliance through three critical reports: Post-Market Surveillance Reports for safety and performance monitoring, Periodic Safety Update Reports for comprehensive benefit-risk analysis, and Post-Market Clinical Follow-Up Reports for real-world clinical evidence evaluation.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation) and various FDA guidance documents:
  • Post-market surveillance studies under 21 CFR 822 require periodic reporting to FDA
  • Real-World Evidence (RWE) submissions support regulatory decision-making
  • Premarket Approval (PMA) devices require periodic safety updates under 21 CFR 814.84
  • Risk Evaluation and Mitigation Strategies (REMS) assessments for certain devices
  • Systematic data collection and trend analysis must be documented
Special attention required for:
  • Devices under FDA enforcement actions requiring enhanced surveillance
  • Class III devices with intensive surveillance requirements
  • Software updates affecting safety profiles requiring validation
  • Post-market study commitments requiring compliance reporting

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Overview

Surveillance Reports provide regulatory evidence of your active commitment to monitoring device safety and performance throughout the post-market lifecycle. This card ensures that you systematically collect, analyze, and report comprehensive data that demonstrates ongoing device safety, effectiveness, and compliance with essential requirements while identifying emerging risks requiring intervention. The Post-Market Surveillance Report serves as your primary evidence of systematic safety monitoring by synthesizing vigilance data, complaints, incidents, and trend analyses collected during defined surveillance periods. These reports demonstrate your capability to identify safety signals, assess their clinical significance, and implement appropriate risk controls. The comprehensive analysis includes statistical trend evaluation, international vigilance database searches, and integration with your corrective and preventive action systems to ensure systematic response to emerging safety concerns. Periodic Safety Update Reports provide comprehensive benefit-risk analysis specifically required for implantable devices and certain high-risk medical devices. Unlike standard surveillance reports, PSURs require integration of clinical data, real-world evidence, and safety signals to support continued market authorization decisions. These reports demonstrate that device benefits continue to outweigh risks as clinical experience accumulates, providing notified bodies and competent authorities with evidence needed for certificate renewals and ongoing compliance assessments. Post-Market Clinical Follow-Up Reports document real-world clinical evidence collected through systematic PMCF activities outlined in your PMCF plan. These reports integrate literature findings, registry studies, user surveys, and clinical data collection to verify that pre-market clinical evaluation conclusions remain valid in real-world use environments. PMCF reports provide evidence of continued clinical effectiveness, user satisfaction, and appropriate real-world performance while identifying any discrepancies requiring clinical evaluation updates. Together, these three reports create a comprehensive surveillance evidence base that supports regulatory compliance, demonstrates systematic quality improvement, and provides objective evidence of ongoing device safety and effectiveness. The reports enable proactive risk management by identifying trends before they become serious incidents, support strategic decision-making through comprehensive data analysis, and maintain stakeholder confidence through transparent safety communication. The surveillance reporting process integrates seamlessly with your vigilance system for incident data, CAPA processes for systematic improvement, risk management for hazard assessment, and clinical evaluation for benefit-risk updates. This integration ensures that surveillance findings transform into actionable improvements while maintaining the rigorous documentation standards required for medical device post-market oversight. The systematic approach to surveillance reporting demonstrates your commitment to continuous monitoring and evidence-based decision-making throughout the device lifecycle. By providing comprehensive analysis of real-world performance data, these reports enable regulatory authorities to assess ongoing device safety, support market access decisions, and ensure that patients continue to receive safe and effective medical devices as clinical experience expands.