11 Acknowledgment handling

Whenever the ACK from PMDA is imported:

• If it is a positive ACK, then a new row is added under Case Form > Product tab > Device sub tab > PMDA Management Information section with the system date and PMDA Control Number populated from M.1.2 (Year) and M.1.3 (Report Reference Number) from the ACK.
• If a negative ACK is imported, then no new row is added.
• If an initial report is submitted to PMDA, M.2.5.1 (report count) is set as 1. If the initial report is rejected by PMDA, then the agency expects the subsequent corrected report to be submitted with the same report count set to 1. If the report is accepted by PMDA, then the agency expects the subsequent report to be submitted with the incremented report count set to 2. Due to this reason, a new row is added in the PMDA Management Information section only for a positive ACK.

The mapping logic calculates the report count value considering the value in the previous positive ACK and increments it by 1. It is recommended that you import the ACK for the submitted report before generating the next follow-up report. Otherwise, the report count might have an incorrect value and the report sequence could be incorrect.