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CSMS #50399421 - FDA to Reject Entry Data When It Contradicts with the Entry Type
U.S. Food and Drug Administration (FDA) validations will be updated to enforce the PGA Flag Enforcement table. If FDA receives an entry with the FDA message set on an entry type not subject to FDA import requirements, FDA will reject the entry data with subreason code 195, Entry Type Not Allowed for PGA.
Specifically, if FDA receives the following entry types the entry data will be rejected for correction of the conflicting information: Entry Type 22, 31, 32, 34 and 38.
This enhancement will be deployed in the lower environment for testing on December 17, 2021, at approximately 10PM. Testing is encouraged. This enhancement will be deployed in production on January 15, 2022, at approximately 10PM.
For questions regarding this reject or FDA ACE technical inquiries, contact FDA ACE Support, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8:00 AM - 8:00 PM.
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