Post-Market Surveillance Plan Requirements
Is a formal PMS plan required?
Unlike the EU MDR/IVDR (which mandates a specific Post-Market Surveillance plan document), FDA does not have a regulation explicitly requiring a standalone "PMS Plan" document for most device types. However:
- PMA conditions of approval often specify post-approval study requirements
- § 522 orders mandate a formal study plan
- Good regulatory practice — and QMSR's quality system provisions — support maintaining a proactive post-market monitoring programme
What a proactive PMS programme should include
| Element | Description |
|---|---|
| Complaint monitoring | Systematic review of customer complaints and MDR trends |
| MDR trend analysis | Periodic analysis of MDRs to identify signals |
| MAUDE monitoring | Review of publicly available MDRs for the device type |
| Literature monitoring | Systematic review of published clinical literature |
| Registry participation | Participation in applicable device registries |
| Recall monitoring | Tracking competitor recalls for related device types |
| CAPA integration | Linking PMS findings to the CAPA system |
QMSR and post-market activities
Under 21 CFR Part 820 (QMSR), manufacturers must:
- Maintain complaint files (§ 820.198)
- Conduct analysis of quality data (§ 820.250)
- Implement corrective and preventive action (CAPA) based on post-market findings