CSMS 50666399PGAACE OPSprocedural

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

Published Jan 11, 2022

Summary

FDA will update validations to reject entry data when FDA message set data is submitted on an entry type not subject to FDA requirements (e.g., Entry Type 22), using reject subreason code 195; this production deployment is now scheduled for January 22, 2022.

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

CSMS 50666399 · full bulletin