Pamela Davol
Ximedica, USA
Title: Evaluating the labeling user-interface and device design-user interface in usability validation studies for combination products: Resolving the catch-22
Biography
Biography: Pamela Davol
Abstract
The strategy of the Center for Devices and Radiological Health (CDRH) at 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 harm 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. For example, the CDRH human factors testing requirementassumes that a pre-requisite for CDER’s testing for labeling is met before conducting a usability validation study (thus prompting of end-users to refer to product instructions is not allowed to re-create a real-life situation); however, CDER requirement for testing assumes that the device design-user interface evaluation has been completed so that a thorough evaluation of labeling comprehension can be acquired for all end-users tested (thus encouraging an evaluation whereby all end-users should be prompted to use the IFU during their use-scenarios) . This incongruence in approach often leads to strategies whereby the requirements of one center may be invalidated by the requirements of the other, thus presenting a significant challenge to companies aspiring to launch combination products consisting of both device and drug constituents, which must satisfy the HF testing requirements of both centers