CSMS 50999050PGAprocedural

Food and Drug Administration (FDA) Receiving Contradicting FSVP ACE Data Elements

Published Feb 14, 2022

Summary

FDA is receiving PGA lines with contradicting FSVP data elements (Entity Role Code FSV combined with exemption codes FSX or RNE) and asks filers and software vendors to correct or prevent this conflicting data, noting future ACE logic will block such combinations.

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

CSMS 50999050 · full bulletin