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# Guide on ‘Comparative Analyses’ for Generic Combination Products
- URL: https://www.fdaweb.com/guide-on-comparative-analyses-for-generic-combination-products/
- Published: 2017-01-13T12:00:00.000Z
- Updated: 2026-09-14T22:00:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137722

FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536959.pdf?ref=fdaweb.com) on “Comparative Analyses and Related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. “In the early stages of development, potential applicants should carefully consider the design of the user interface of a proposed generic combination product and seek to minimize differences from the user interface for the RLD,” it says. To facilitate that process, the guidance provides general principles, including how to conduct threshold analyses for the identification and the assessment of differences in the design of the user interface for the proposed generic combination product when compared to its RLD.