FDA Seeks Comments on Proposed Update to Breakthrough Devices Program Intended to Reduce Health Disparities

“Health and health care disparities exist and occur across many dimensions, including race, ethnicity, socioeconomic status, age, sex, disability status, sexual orientation, gender identity, language, and location, among others, as summarized in reports by the Agency for Healthcare Research and Quality and Department of Health and Human Services Office of Minority Health. Addressing health and health care disparities is not only important for achieving health equity, but also for improving the overall quality of life and health outcomes for all patients.”

“One dimension contributing to health and health care disparities is the inability to recognize and address the ways in which treatment outcomes may differ by race, ethnicity, sex, and/or other factors. For some diseases, the pathophysiology, clinical features, and response to treatment may be impacted by these factors. Health and health care disparities can be exacerbated due to a lack of recognition of these differences, including implicit biases, and/or the lack of devices designed to effectively diagnose or treat the condition in a manner that addresses these differences. The Breakthrough Devices Program can be used to provide more timely access to devices that address the unmet needs of populations that may experience health and/or health care disparities. For example, as part of FDA’s assessment of whether a device is reasonably expected to be more effective, we consider if it is designed to address a pathophysiological or clinical characteristic associated with certain populations that could have a clinically meaningful impact for the treatment or diagnosis of the condition in those populations. Such a device may, therefore, be considered as reasonably expected to offer a more effective treatment or diagnosis as is consistent with criterion 1 of the designation criteria. FDA considers technologies and device features tailored to address characteristic differences, such as those arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment, when evaluating if there is a reasonable expectation that the device may provide for more effective treatment or diagnosis as compared to the current standard of care, including the device’s potential to be more effective in certain populations.”