FDA MDR ENFORCEMENT ACTIONS: BEST PRACTICES FOR STRENGTHENING MEDWATCH FORM WRITING AND REPORTING

A common enforcement action sited in FDA warning letters in recent years pertains to the failure to properly and fully complete a MedWatch Form (FDA 3500A). Complaint reporting teams are tasked with compiling these complex reports and ensuring that the information entered is consistent with underlying complaint files and internal documents. In order to ensure compliance with the FDA, device manufacturers must ensure that MedWatch forms are factual and fully per FDA requirements.

• In-depth review of MedWatch report requirements and writing techniques
  • Determining what details to include
  • Mitigating the use of speculative language
  • Recognizing overall writing tone
• Comparison of complaint files vs. MedWatch reports to ensure consistency
• Addressing common MedWatch pitfalls and strategies to overcome

Speaker:
Adriana M. Russell
Quality Assurance
Formerly of Zimmer Biomet