Table of Contents

• Title and Copyright Information
• Preface
  • Documentation accessibility
  • Diversity and inclusion
  • Related resources
  • Access to Oracle Support
• 1 Revision history
• 2 Introduction
• 3 PMDA Device support in Oracle Argus Safety
• 4 Configuration updates in Argus Console
• 5 Setting up reporting destinations
• 6 Setting up reporting rules
• 7 Medical Device Defect Glossary
• 8 Legacy device case reporting
  • Business configuration - License
  • Follow-up for a legacy case
  • PMDA device paper reports for a legacy case
  • Reports submitted in old format and subsequently in XML outside Oracle Argus
• 9 Handling case copy in PMDA Device reportable cases
• 10 Nullification reporting
  • Nullification reporting – Form 8
  • Nullification reporting – Form 10
• 11 Acknowledgment handling
• 12 Observations during PMDA testing
• 13 Frequently asked questions (FAQs)
  • Can we re-use the existing agency configuration for XML reporting?
  • Can we send a follow-up report in the new XML format for a legacy case having submitted the paper form 8 or paper form 10?
  • Is it required to specify the ACK profile in the Reporting Destination?
  • Can I edit local fields when a case is globally locked but locally unlocked?