Evaluating the Labeling-User Interface and Device Design-User Interface in Usability Validation Studies for Combination Products: Resolving the Catch-22

Abstract

The strategy of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for usability validation of medical devices is aimed at the priority of evaluating device design as a means to reduce risks through mitigation of use-errors that may present serious harms to end-users and patients. In contrast, the strategy of the Center for Drug Evaluation and Research (CDER) is aimed at evaluating product packaging and labeling to ensure end-user comprehension of drug and delivery device instructions-for-use (IFU) and other labeling as a means to minimize risks for medication errors that may result in harms to the patient or ineffective drug treatment. Although both strategies align to a common purpose, each FDA Center's requirement often presents a Catch-22, particularly when product Sponsors postpone usability evaluations and try to combine each Center's requirements for the purpose of fulfilling usability validation requirements. Although not the ideal strategy, the purpose of this presentation is to discuss and compare past-proven methods that have been successful for satisfying the usability validation testing requirements of both CDRH and CDER for combination products when Sponsors have not conducted usability evaluations throughout a product's development. This in-depth presentation will include a discussion of Centers' requirements that are in direct opposition to each other and alternative methods for usability validation testing to satisfy both Centers. Strengths and limitations of each strategy will be discussed in relation to the overall usability validation testing process. Recognizing and understanding usability validation testing strategies of CDRH and CDER that are in direct opposition of each other in advance is essential for applying a human factors usability strategy that leads to the successful validation of a combination product. Knowledge of alternative testing strategies, each with their own strengths and limitations, designed to meet expectations of both Centers allows HF usability investigators to select and/or tailor the approach that best meets the unique challenges of their investigational combination product in order to efficiently pass validation from both Centers and enter the market.