Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations

Recommended Actions

1. Develop a standardized template for Dear Doctor letters following the recommended format and content structure
2. Establish a process for rapid communication development and distribution
3. Create a dedicated webpage for posting Dear Doctor letters and updates
4. Set up multiple communication channels for distributing the letters
5. Implement a review process to ensure all critical information is included
6. Establish a system for tracking affected devices and patient follow-up
7. Create a protocol for handling returned explanted devices
8. Develop patient communication materials that physicians can use
9. Set up dedicated contact points for healthcare professional inquiries
10. Establish a process for providing regular updates as new information becomes available

Key Considerations

Clinical testing

• Provide interrogation steps or clinical tests to identify devices that have failed or may fail
• Include recommended follow-up schedules for affected patients

Human Factors

• Present safety information in a consistent order
• Format letters for easy readability (large font, bold type, high contrast, subheadings)
• Avoid lengthy background information
• Keep communications concise (less than two pages when possible)

Labelling

• Include clear description of the problem and failure mode
• Provide detailed information about affected devices and scope of the issue
• Include company contact information and resources for additional information

Software

• Specify if failure mode can be corrected through reprogramming or software upgrades
• Explain if software fixes are permanent solutions or interim measures

Safety

• Report number of deaths and injuries related to device failure
• Include severity and likelihood of the problem
• Provide clear recommendations for patient treatment options
• Include instructions for device explantation when necessary

Other considerations

• Use multiple communication channels (email, fax, express mail, web)
• Avoid promotional statements about the company
• Focus on patient care rather than company liability
• Provide timely communications before media coverage
• Include instructions for returning explanted devices

  Relevant Guidances

• Distinguishing Between Medical Device Recalls and Device Enhancements
• Public Warning and Notification of Recalls Under Part 7
• Product Recalls, Removals, and Corrections: Procedures and Best Practices

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Original guidance

• Dear Doctor Letters for Implantable Cardioverter Defibrillator Recalls: Content and Format Recommendations
• HTML / PDF
• Issue date: 2007-07-19
• Last changed date: 2020-03-19
• Status: FINAL
• Official FDA topics: Medical Devices, Radiation-Emitting Products, Postmarket, Radiological Health
• ReguVirta summary file ID: 63376a496577d5ff88bfa89d3e4c8b00