# Battelle User Interface Design for Generic vs. RLD Combination Products

> **NIH FDA U01** · BATTELLE CENTERS/PUB HLTH RES & EVALUATN · 2021 · $199,995

## Abstract

PROJECT SUMMARY/ABSTRACT
In 2019, the Food and Drug Administration issued approvals for generic combination products including
the Fluticasone and Salmeterol Inhalation Powder and the Naloxone Nasal Spray. Generic devices like
these have the potential to cause harm to a patient or user if the user interface is not carefully evaluated
to ensure a generic product’s user interface is substitutable when compared to that of its reference listed
drug (RLD). Understanding the factors that could impact safe and effective use is critical when evaluating
a generic combination product as there is a higher likelihood for use error resulting from a user’s pre-
existing mental model, based on use experience with the RLD. Additionally, the reliance of an abbreviated
new drug application (ANDA) on FDA’s findings that the RLD is safe and effective relies on the premise
that there are no user interface differences that would undermine the therapeutic equivalence of the
generic to the RLD. Battelle applies a risk-based human-centric design (HCD) approach to medical
device development that predates FDA guidance on the subject. Battelle will modify this approach to
develop methods for effectively evaluating a generic device against an RLD. Battelle will collaborate with
the federal research team to accomplish the following two (2) aims:
Aim 1: Develop enhanced methods for threshold analysis and categorization of user interface
differences. Battelle will leverage extensive device development and human factors expertise to
collaborate with the FDA to develop a risk-based approach to support the categorization of differences
in the design of a user interface. Battelle will select specific representative combination products for
analysis. Battelle will implement or modify their existing usability engineering (UE) methods to perform
use risk analyses of key elements of the selected devices to support the appropriate categorization of
the user interfaces.
Aim 2: Establish effective methods for assessing “other” design differences.” Battelle will utilize their in-
house expertise to develop custom methods for evaluation and data collection. Combined with
Battelle’s experience developing creative modeling solutions for a variety of human tissue types,
Battelle will produce methods that will accurately assess whether "other" differences in the user
interface introduce a risk that might impact the clinical effect or safety profile of the generic drug-device
combination product as compared to the RLD.
The evaluation methods developed by Battelle and the federal research team will be applicable for all
stakeholders engaged in the development of generic drug-device combination products. This effort will
result in an improved set of tools for evaluating how differences in the user interface of a proposed
generic combination product as compared to the RLD may impact the overall use of a product.

## Key facts

- **NIH application ID:** 10377279
- **Project number:** 1U01FD007359-01
- **Recipient organization:** BATTELLE CENTERS/PUB HLTH RES & EVALUATN
- **Principal Investigator:** Jessica Sanford
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $199,995
- **Award type:** 1
- **Project period:** 2021-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10377279

## Citation

> US National Institutes of Health, RePORTER application 10377279, Battelle User Interface Design for Generic vs. RLD Combination Products (1U01FD007359-01). Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/grant/nih/10377279. Licensed CC0.

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