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# GDUFA Completeness Assessment Guidance Out
- URL: https://www.fdaweb.com/gdufa-completeness-assessment-guidance-out/
- Published: 2017-10-04T12:00:00.000Z
- Updated: 2026-09-14T22:54:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139777

FDA has issued a guidance, *Completeness Assessment for Type 11 API DMFs Under GDUFA*, to explain to holders of Type II active pharmaceutical ingredient drug master files (DMFs) that are or will be referenced in an ANDA, amendment to an ANDA, PSA to an ANDA, or a PSA amendment, requirements imposed as of 10/1/12 under GDUFA. Under the legislation, the [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf?ref=fdaweb.com) says, DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application, and Type II API DMFs must undergo an FDA completeness assessment (CA).

The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA. It does not apply to Type II API DMFs used to support NDAs, BLAs, other submissions that are not generic drug submissions, or any other types of DMFs.