CAPAs and Vigilance
Field Safety Notice Form
Communicate urgent safety information to users requiring immediate protective actions.
Summary
A Field Safety Notice Form is an urgent communication template used to notify users, patients, and healthcare professionals about safety issues with your medical device that require immediate action. You use this form when you identify risks that could cause serious harm and need to implement Field Safety Corrective Actions (FSCA) to protect users.Why is the Field Safety Notice Form important?
Field Safety Notice Forms serve as your primary tool for rapid and standardized risk communication when post-market surveillance reveals safety concerns. They enable you to quickly inform users about hazards, provide protective instructions, and coordinate corrective actions before serious incidents occur using a consistent format. FSN forms demonstrate regulatory compliance, protect patient safety, and maintain stakeholder trust during crisis situations. Without timely and effective FSN forms, safety issues can escalate into widespread harm, regulatory sanctions, and permanent market withdrawal.Regulatory Context
Under 21 CFR Part 806 (Medical Device Correction and Removal):
- Manufacturers must notify FDA within 10 working days of initiating a correction or removal
- Device recalls must be reported immediately if they could cause serious health consequences
- FSNs must reach all affected users and include specific corrective actions
- Follow-up reports required to document effectiveness of corrective actions
Special attention required for:
- Class I recalls requiring immediate FDA notification
- Software updates that address safety-critical vulnerabilities
- Devices used in life-supporting or life-sustaining applications
- Coordination with FDA’s MedWatch safety alert system
Guide
When to Use the Field Safety Notice Form
Use the FSN form template immediately when you identify device-related risks that could cause death, serious injury, or serious public health threats. This includes software malfunctions, hardware failures, labeling errors, or use-errors that compromise safety. Don’t delay for complete investigations - use the preliminary FSN form based on initial risk assessments and follow up with additional information as your investigation progresses. The goal is rapid risk mitigation, not perfect information.FSN Form Content Requirements
Risk description must clearly explain the hazard, its likelihood, and potential consequences for users and patients using the structured form fields. Use plain language that non-technical users can understand while providing sufficient detail for healthcare professionals to make informed decisions. Corrective actions should be specific, actionable, and time-bound using the form template. Specify exactly what users must do, by when, and how to confirm completion. Include contact information for questions and support during implementation. Device identification must enable users to determine if their devices are affected using the form’s device information section. Include UDI-DI numbers, software versions, serial number ranges, and manufacturing dates as applicable.Distribution and Follow-up
Reach all affected users through multiple channels including direct mail, email, website postings, and professional networks using the completed form. Maintain distribution lists and track delivery confirmation to ensure comprehensive coverage. Monitor implementation by tracking user responses, measuring corrective action completion rates, and assessing residual risk levels. Document effectiveness and prepare follow-up communications as needed. Coordinate with authorities by submitting completed FSN forms to competent authorities simultaneously with user distribution. Provide regular updates on implementation progress and effectiveness measurements.Integration with Quality Management
Connect your FSN form process to your incident management system for rapid response to emerging safety signals. Link to your CAPA system to address root causes and prevent recurrence. Update your risk management file to reflect new hazards and control measures identified through FSN activities.Example
Scenario: Your cardiac monitoring app experiences a critical software bug that causes false arrhythmia alarms in 2% of users, leading to unnecessary emergency room visits. Post-market surveillance data shows this affects version 3.2.1 released three weeks ago. You must immediately issue an FSN to prevent further incidents while developing a software fix.Example Field Safety Notice Form
FSN Number: FSN-2024-001Date: March 20, 2024 URGENT FIELD SAFETY NOTICE CardioWatch Pro Mobile App For the Attention of: All CardioWatch Pro users, cardiologists, and healthcare facilities using our cardiac monitoring system Contact Details of Local Representative: CardioWatch Support Team
Email: safety@cardiowatch.com
Phone: +49-30-12345678
Address: Medizintechnik Straße 15, 10115 Berlin, Germany
Device Information
| Device Information | Description |
|---|---|
| Device Name | CardioWatch Pro Mobile App |
| Device UDI-DI | (01)04012345123456 |
| Manufacturer Name | CardioWatch Technologies GmbH |
| Single Registration Number (SRN) | DE-MF-000012345 |
| Device Description | Mobile application for continuous cardiac rhythm monitoring and arrhythmia detection in ambulatory patients |
| Associated Devices Affected | CardioWatch Pro Hardware Sensor (Model CW-100) when used with affected app version |
Risk Information
| Risk Information | Description |
|---|---|
| Description of Product Issue | Software algorithm error in version 3.2.1 causing false positive arrhythmia alerts in approximately 2% of monitoring sessions |
| Hazard Resulting from Issue | Unnecessary emergency medical interventions, patient anxiety, healthcare system burden, and potential delayed response to actual emergencies |
| Likelihood of Risk | Moderate - affects 2% of monitoring sessions, with higher incidence in patients with baseline heart rate variability |
| Risk to Users/Patients | Patients: Unnecessary stress, emergency room visits, potential medical procedures. Healthcare providers: Resource allocation issues, diagnostic confusion |
| Additional Information | Issue identified through post-market surveillance analysis of user reports. Root cause: algorithm sensitivity threshold error introduced in version 3.2.1 update |
Action Information
| Action Information | Description |
|---|---|
| Action to be Taken by User | Immediately update CardioWatch Pro app to version 3.2.2 (available now). Verify alert settings are configured correctly. Contact physician if you received false alarms in the past 3 weeks |
| User Action Timeline | Update app within 48 hours of receiving this notice |
| Customer Reply Required | Yes - Confirm app update completion via email to safety@cardiowatch.com or through in-app notification |
| Action Taken by Manufacturer | Released corrected software version 3.2.2 with fixed algorithm. Implementing enhanced testing protocols for future releases. Notifying regulatory authorities and healthcare networks |
| Manufacturer Action Timeline | Software fix released March 20, 2024. Enhanced testing protocols implemented by April 1, 2024 |
| Information for Lay Patient or User | For patients: Update your app immediately. If you visited emergency care due to CardioWatch alerts in the past 3 weeks, inform your doctor about this notice. Continue normal monitoring - the device remains safe and effective with the update |
Q&A
How quickly must Field Safety Notices be distributed?
How quickly must Field Safety Notices be distributed?
Distribute FSNs immediately upon identifying safety risks - within 24-48 hours of risk confirmation. Don’t wait for complete investigations. Issue preliminary notices and follow up with additional information as it becomes available.
What languages are required for FSN distribution?
What languages are required for FSN distribution?
FSNs must be provided in the local language of each market where your device is distributed. For EU markets, this typically means translating into the official language(s) of each member state where you have users.
How do you ensure FSNs reach all affected users?
How do you ensure FSNs reach all affected users?
Maintain comprehensive user databases with multiple contact methods. Use direct mail, email, website postings, professional networks, and distributor channels. Track delivery confirmation and follow up with non-responders through alternative channels.
When should you issue follow-up Field Safety Notices?
When should you issue follow-up Field Safety Notices?
Issue follow-up FSNs when you have significant new information about the risk, when initial corrective actions prove insufficient, or when you need to report on implementation effectiveness. Regular follow-ups may be required until the safety issue is fully resolved.
What happens if users don't respond to Field Safety Notices?
What happens if users don't respond to Field Safety Notices?
Implement escalating communication strategies including repeat notices through different channels, direct phone contact for high-risk situations, and coordination with healthcare providers. Document all attempts and consider additional regulatory reporting for non-responsive users in critical situations.