CSMS 50399421PGAACE OPSprocedural

FDA to Reject Entry Data When It Contradicts with the Entry Type

Published Dec 15, 2021

Summary

FDA will update ACE validations to enforce the PGA Flag Enforcement table, rejecting entries with an FDA message set on entry types not subject to FDA requirements (e.g., 22, 31, 32, 34, 38) using subreason code 195, with deployment in test on December 17, 2021 and production on January 15, 2022.

Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.

CSMS 50399421 · full bulletin