FdaAffirmationOfCompliance

Type.

alternates

•

[FdaAffirmationOfCompliance!]

Mutually exclusive alternatives to this affirmation (e.g., FME as alternate to PFR).

category

•

FdaAffirmationCategory

What triggers this affirmation and where it comes from during message-set assembly.

code

•

String!

Required

3-letter code (e.g., PFR, FME, BLN) for PG14 in ACE filing.

condition

•

String

Condition describing when this AoC is required. Null if always required.

confidenceScore

•

Decimal

AI confidence score (0-1) for this determination.

name

•

String!

Required

Full name of the affirmation.

qualifier

•

FdaAffirmationQualifier

Qualifier details for PG15 in ACE filing. Null if no qualifier needed (indicator-only AoC).