Oracle Argus Safety PMDA Device Reporting Best Practices

This document is a guide detailing the PMDA Device Reporting Best Practices for Oracle Argus Safety, specifically for Release 8.4.4. It outlines the support for PMDA Device Form 8 and Form 10 reports in both XML and paper formats, which are mandatory as of April 1, 2021. The guide includes configuration updates in the Argus Console, emphasizing the importance of adhering to the revised templates and regulatory guidance published by MHLW. It describes the updates to the Device Reporting Category values and introduces a new common profile switch for file attachments. Best practices for configuring the PMDA Device Profile are also provided, including customization options for transmitting logic and managing data elements specific to Form 8 and Form 10. The document serves as a comprehensive resource for ensuring compliance with PMDA reporting requirements and optimizing the use of Oracle Argus Safety for medical device reporting.