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Summary

The Post-Market Surveillance Plan establishes your systematic approach to monitoring device safety and performance after market release. This plan defines data collection methods, analysis procedures, and reporting requirements to ensure ongoing compliance with regulatory obligations and patient safety.

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Why is Post-Market Surveillance Plan important?

Post-market surveillance exists because real-world device performance often differs from controlled testing environments. Regulatory authorities require manufacturers to continuously monitor their devices to identify previously unknown risks, confirm expected performance, and detect emerging safety issues. This proactive monitoring protects patients, maintains regulatory compliance, and provides valuable data for device improvements. Without a structured surveillance plan, you risk missing critical safety signals that could lead to patient harm, regulatory enforcement actions, or costly device recalls.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 803 (Medical Device Reporting):

  • Post-market surveillance is mandatory under Section 820.100 (Corrective and Preventive Actions)
  • Must establish procedures for data collection and analysis from various sources
  • Medical Device Reporting (MDR) requires reporting of deaths, serious injuries, and malfunctions
  • Periodic reporting may be required for certain device types

Special attention required for:

  • Software medical devices requiring cybersecurity monitoring (FDA Guidance 2022)
  • Class III devices with enhanced post-market study requirements
  • Devices with FDA-mandated post-market studies as condition of approval
  • Unique Device Identification (UDI) integration for traceability

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Guide

Your Post-Market Surveillance Plan must establish systematic procedures for collecting, analyzing, and acting on post-market data. The plan serves as your roadmap for ongoing device monitoring and regulatory compliance.

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Data Collection Sources

Define comprehensive data inputs that will provide visibility into device performance. Your plan must specify how you’ll collect information from vigilance databases, including FDA MAUDE, BfArM, and Swissmedic systems. Establish search keywords specific to your device type and intended use to ensure relevant incident identification. Include procedures for monitoring complaints and feedback from users, distributors, and healthcare providers.

Establish complaint management integration by defining which complaints require logging in your quality management system versus general customer support issues. Focus on complaints related to device performance, safety concerns, or unexpected behaviors that could indicate emerging risks.

Plan for literature and registry monitoring by identifying relevant medical journals, conference proceedings, and device registries that may contain safety information about your device or similar products. This includes monitoring competitor recalls and field safety notices that might indicate industry-wide issues.

Implement statistical trend analysis using appropriate methods such as the Mann-Kendall test for identifying significant increases in incident frequency or severity. Define your significance thresholds (typically p-value < 0.05) and establish procedures for investigating positive trends.

Calculate complaint rates by comparing complaint volumes against device sales or installation numbers. This provides context for determining whether complaint levels represent normal variation or concerning trends requiring investigation.

Establish risk assessment integration by defining how post-market findings will trigger updates to your risk management file. Include procedures for determining when new risks require immediate reporting versus inclusion in periodic reports.

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Reporting and Documentation Requirements

Define reporting timelines based on your device classification and regulatory requirements. Specify when you’ll generate Post-Market Surveillance Reports, Periodic Safety Update Reports, or other required documentation.

Establish escalation procedures for serious incidents requiring immediate regulatory notification. Include clear criteria for determining reportability and timelines for submission to appropriate authorities.

Plan for corrective action integration by defining how surveillance findings will trigger your CAPA system when risks exceed acceptable levels or new hazards are identified.

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Implementation and Review Procedures

Assign responsibilities for surveillance activities, including data collection, analysis, and reporting. Ensure personnel have appropriate training and access to necessary databases and systems.

Establish review frequencies for surveillance data analysis. While formal reports may be annual, ongoing monitoring should occur more frequently to enable rapid response to emerging issues.

Plan for surveillance plan updates as your device evolves, market conditions change, or regulatory requirements are modified. Include procedures for version control and approval of plan revisions.

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Example

Scenario: You manufacture a mobile health app that monitors blood glucose levels and provides dosing recommendations. Your Post-Market Surveillance Plan establishes monthly vigilance database searches, quarterly complaint analysis, and annual comprehensive reporting.

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Post-Market Surveillance Plan for GlucoTrack Mobile Health Application

1. Scope This plan describes post-market surveillance activities for GlucoTrack v2.1, a Class II mobile medical device application for diabetes management. The plan addresses data collection from vigilance databases, user complaints, and clinical literature to ensure ongoing device safety and performance monitoring.

2. PMS Data Inputs

2.1 Vigilance Data Monthly searches of FDA MAUDE, BfArM, and Swissmedic databases using keywords: “glucose monitoring app,” “diabetes software,” “insulin dosing error,” “hypoglycemic event,” “mobile health device malfunction.”

2.2 Complaints Data Integration with customer support system to identify complaints related to:

  • Incorrect glucose readings or calculations
  • App crashes during critical functions
  • Dosing recommendation errors
  • Data synchronization failures
  • User interface confusion leading to medication errors

Complaint rate calculation: Monthly complaints ÷ Active monthly users × 1000

2.3 Literature Monitoring Quarterly review of diabetes technology journals and conference proceedings for reports of similar device issues or emerging safety concerns.

3. Trend Analysis Methodology Mann-Kendall test applied to monthly complaint data with significance threshold p < 0.05. Positive trends trigger immediate investigation and potential risk assessment updates.

4. Reporting Schedule

  • Monthly: Internal surveillance data review
  • Quarterly: Complaint trend analysis and literature review
  • Annually: Comprehensive Post-Market Surveillance Report
  • As needed: Serious incident reports within 24 hours of identification

5. Responsibilities Quality Assurance Manager: Database monitoring and trend analysis Regulatory Affairs Specialist: Report preparation and submission Clinical Affairs: Literature review and clinical significance assessment

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Q&A