# Field Safety Corrective Action

> Use this template to fSCA plan and notice for [device_issue].

## Template Metadata

| Field | Details |
|-------|---------|
| Category | Medical Devices |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |

## Issue Summary

Describe the field issue, discovery source, potential hazard, and FSCA decision.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Affected Devices

Identify product names, models, UDI, serial or lot ranges, distribution dates, and markets.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Health Hazard Evaluation

Summarize probability of occurrence, severity, exposed population, and medical consequences.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Corrective Action

Describe removal, correction, software update, labeling change, inspection, or customer communication.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Customer Instructions

Provide clear actions for consignees, users, distributors, and return acknowledgements.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Regulatory Notifications

List authorities, report numbers, timelines, and field safety notice controls.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Effectiveness Tracking

Define response targets, reconciliation, follow-up attempts, and closure criteria. Use direct, controlled language suitable for QA and regulatory review.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Review and Signoff

Document review conclusions, approvals, unresolved items, and next review date.

| Role | Name | Date | Notes |
|------|------|------|-------|
| Preparer | [Name] | [Date] | [Notes] |
| Reviewer | [Name] | [Date] | [Notes] |
| Approver | [Name] | [Date] | [Notes] |