Follow-up for a legacy case

Whenever there is a received follow-up information, which makes the existing legacy device case reportable to PMDA, you must ensure the following data is updated or added before generating the follow-up device report:

1. Device Reporting Category under Case Form > Product > Device > PMDA device information section is updated to select the corresponding new category value.
2. You must ensure that the mandatory fields required for PMDA Device reporting are available. For the list of mandatory fields required for reporting, refer to the Validation sheet in the PMDA Device Mapping document for Form 8 and Form 10.xlsx mapping document and filter by the Validation column for the Mandatory value.
3. The PMDA acknowledgment number for old paper form was in the format XXXXX-YY. Oracle Argus Safety supported data entry in this format in Case Form > Product tab > Device sub tab > PMDA Management Information section > Acknowledgment number field. If an XML is generated for the same case having the paper form submissions, then the PREVIOUSREPORTREFERENCENUMBER [M.2.5.3] element is expected to be in the following format: 1-to-6-digit numerical value + 1-to-2-digit alphabet value for the previous acknowledgment number. It is recommended that you accordingly update the acknowledgment number in the PMDA Management Information section.