FSN

A Field Safety Notice (FSN) is the formal communication method required under EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) to inform users, customers, and competent authorities about Field Safety Corrective Actions (FSCA) being implemented for medical devices in the field.

Regulatory foundation:

EU MDR Article 83 - Field Safety Corrective Actions:
When manufacturers implement FSCAs, they must inform users and customers by means of Field Safety Notices. The FSN serves as the official notification mechanism ensuring that all stakeholders are aware of safety issues and required actions.

MDCG 2019-9 Guidance:
The Medical Device Coordination Group (MDCG) published guidance document MDCG 2019-9 "Field Safety Notice template for manufacturers and template for a manufacturer's summary of Field Safety Corrective Actions" providing standardized templates and requirements for FSN creation and distribution.

Purpose and objectives of FSN:

Primary purposes:
- Inform users about identified safety risks
- Provide clear instructions for corrective actions
- Enable traceability of affected devices
- Document manufacturer's safety response
- Fulfill regulatory notification obligations
- Protect patient safety through timely communication

Target audiences:
- Healthcare facilities using affected devices
- Distributors and importers in supply chain
- Patients (when direct patient notification appropriate)
- National competent authorities
- Notified Bodies
- Authorized Representatives

Mandatory FSN content per MDCG 2019-9:

Header information:
- Document title: "FIELD SAFETY NOTICE" or "URGENT FIELD SAFETY NOTICE"
- FSN reference number (unique identifier)
- Date of issue
- Manufacturer name and address
- Authorized Representative contact (if applicable)

Section 1 - Device identification:
- Device trade name and common name
- Basic UDI-DI (Unique Device Identifier)
- Device model numbers and catalog numbers
- Affected serial numbers, lot numbers, or batch numbers
- Software version numbers (if applicable)
- Date range of manufacture for affected devices

Section 2 - Reason for FSN:
- Type of action (recall, modification, notice, etc.)
- Identified risk and potential consequences
- Brief description of device issue or defect
- Medical or safety rationale for action

Section 3 - Background information:
- How issue was discovered (incident reports, testing, complaints)
- Number of incidents or complaints received
- Whether any injuries or adverse events occurred
- Timeline of issue identification
- Countries or regions affected

Section 4 - Actions to be taken by customers:
Clear, specific instructions such as:
- Immediately stop using device (if applicable)
- Return device to manufacturer/distributor
- Apply software update or modification
- Implement revised instructions for use
- Contact manufacturer for further instructions
- Complete and return acknowledgment form
- Conduct inventory check for affected devices
- Deadline for completing actions

Section 5 - Transmission information:
- Date of FSN distribution
- Intended recipients and distribution method
- Request for further distribution to end users
- Contact information for questions
- Instructions for confirming receipt

FSN types and classifications:

Urgent Field Safety Notice:
Used for immediate or urgent safety concerns:
- Imminent risk of death or serious injury
- Requires immediate cessation of device use
- Demands rapid user response
- May require direct patient contact

Standard Field Safety Notice:
Used for important but less time-critical issues:
- Significant risk requiring corrective action
- Can be addressed within reasonable timeframe
- May involve scheduled modification or update
- Routine recall or labeling update

Final FSN:
Issued when FSCA is completed:
- Confirms corrective action completion
- Provides closure to initial FSN
- Summarizes outcomes and effectiveness
- May include lessons learned

FSN distribution requirements:

Distribution channels:
- Direct communication to known customers
- Email to registered users
- Postal mail for critical notices
- Phone calls for urgent situations
- Publication on manufacturer website
- Notification through distributor networks

Proof of distribution:
Manufacturers must document:
- Complete list of FSN recipients
- Distribution dates and methods
- Delivery confirmations
- Customer acknowledgment receipts
- Follow-up actions for non-responsive customers
- Records of all communication attempts

Language requirements:
FSN must be provided in the official language(s) of the member state where device is in use. For multi-country distribution, multiple language versions may be required.

Timeline for FSN issuance:

Immediate (within 2 days):
- Death or imminent life-threatening situation
- Critical malfunction requiring immediate action
- Public health emergency involving device

Urgent (within 10 days):
- Serious injury risk identified
- Significant device malfunction discovered
- Safety issue requiring prompt user action

Standard (within 15-30 days):
- Important safety information
- Non-urgent corrective actions
- Labeling or instructions updates

FSN and competent authority notification:

Parallel notification:
Manufacturers must submit FSN to competent authorities simultaneously with or before distribution to customers:
- Each national competent authority in affected countries
- Electronic submission when possible
- EUDAMED electronic system (when fully functional)
- Copy to Notified Body if applicable

Competent authority may:
- Request additional information
- Require modification to FSN content
- Mandate broader distribution
- Order specific timelines for completion
- Conduct inspections to verify compliance

Customer response requirements:

Customer obligations upon receiving FSN:
- Read and understand FSN content immediately
- Identify affected devices in inventory or in use
- Implement requested actions per timeline
- Acknowledge receipt to manufacturer
- Distribute FSN to downstream users/patients
- Document all corrective actions taken
- Report any questions or concerns to manufacturer

Follow-up FSN communications:

Reminder FSN:
Sent if initial FSN response rate inadequate:
- Reminds non-responsive customers
- Provides additional deadline
- May escalate urgency language
- Includes original FSN reference

Updated FSN:
Issued if new information emerges:
- Additional affected devices identified
- Modified corrective action instructions
- Updated risk information
- Clarification of previous FSN

FSN quality and effectiveness:

Best practices for effective FSN:
- Use clear, non-technical language where possible
- Provide specific, actionable instructions
- Include visual aids (photos, diagrams) if helpful
- Highlight key information prominently
- Make FSN easily distinguishable from routine correspondence
- Provide multiple contact methods
- Set realistic but appropriate deadlines
- Include FAQ section for complex issues

Common FSN deficiencies:
- Vague or unclear action instructions
- Missing device identification details
- Inadequate distribution to end users
- Poor translation in local languages
- Delayed issuance relative to risk severity
- Failure to follow MDCG template
- Incomplete contact information
- No verification of customer receipt

FSN documentation and records:

Required documentation:
- FSN master document and all language versions
- Distribution lists with contact details
- Proof of transmission (emails, tracking numbers)
- Customer acknowledgment forms
- Non-response follow-up communications
- Competent authority submission confirmations
- Corrective action completion verifications
- Effectiveness monitoring results

Record retention:
Minimum 10 years after last device manufactured, consistent with technical documentation requirements under MDR/IVDR.

FSN in context of overall vigilance system:

Integration with other post-market activities:
- Serious incident reporting (Article 87)
- Periodic Safety Update Reports (PSUR)
- Post-Market Clinical Follow-up (PMCF)
- Trend analysis and signal detection
- Complaint handling procedures
- Risk management file updates

FSN triggers from vigilance data:
- Pattern of similar complaints or incidents
- Single serious incident revealing systematic issue
- Literature reports or competitor FSCAs
- Regulatory intelligence and alerts
- Internal quality investigations
- Clinical evidence changes

International considerations:

Countries outside EU requiring similar notices:
- UK (Field Safety Notices post-Brexit)
- Switzerland (follows similar requirements)
- Turkey (reference to EU MDR practices)
- Countries accepting EU compliance

FDA comparison (USA):
FDA uses different terminology but similar concept:
- Medical Device Recall notices
- Dear Doctor letters
- Safety Communications
- Not identical format to EU FSN

The Field Safety Notice is a critical patient safety tool that ensures transparent communication when medical devices present risks in the field. Effective FSN creation and distribution demonstrates manufacturer accountability and commitment to user safety.