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# Draft Guide on ANDAs for Drug-Device Combo Products
- URL: https://www.fdaweb.com/draft-guide-on-andas-for-drug-device-combo-products/
- Published: 2017-01-17T12:00:00.000Z
- Updated: 2026-09-14T22:00:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137737

*Federal Register* Notice: FDA has made available a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device combination product when compared to the user interface for the reference listed drug (RLD). This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536959.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-17/pdf/2017-00795.pdf?ref=fdaweb.com).