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Health Equity for Medical Devices: FDA Discussion
(Thursday, August 8, 2024) The Health Equity discussion with the regulated industry has been heavily weighted towards drugs and biologics. However, lack of diversity is an issue for medical device clinical trials as well. The FDA listed several considerations in its discussion paper this week on the topic aiming to collect feedback from the device industry and other stakeholders to help the FDA create specific guidance documents on this topic. There are several examples of diagnostic tests, software medical devices, digital health devices, and other medical devices where lack of diversity in the population in which the devices were tested, led to severe limitations on the potential use of the devices in and by all populations. The Center for Devices (CDRH) is trying to develop a framework for “when a device should be evaluated in diverse populations to support marketing authorization.”. A major challenge to incorporating Health Equity in medical device clinical trials is that very few medical devices require clinical trials in the first place and those that do require human testing, often do not consider the influence of the diversity of the clinical trial participants on the safety and effectiveness of the device. For example, most digital health devices and diagnostic devices, assume no impact of the demographic distribution of the patient population on the study outcomes. The FDA lists three considerations for the clinical development plan for medical devices: 1) The variability of the disease burden in various populations. The sponsor must consider the prevalence, incidence, and severity of the disease or condition in the target patient groups in the context of demographics, socioeconomic status, comorbidities, and access to care. This assessment may be based on relevant public information or non-public information such as the sponsor’s previous clinical trials. 2) Expected differences in clinical outcomes in different patient populations based on physiology, anatomy, and pathophysiology of the disease or condition under study within the context of disease or condition etiology, progression, and prognosis. Variations in these elements may indicate differences in device performance and could help set criteria for clinical site selection, inclusion and exclusion criteria, and clinical outcomes of interest. 3) Performance differences between population groups due to the underlying technology for the device. Sponsors must consider if the underlying design principles, such as physical, mechanical, or electrical, through which the device achieves its intended effect, are impacted by the differences in the intended use population. Are all intended users able to use the device as designed or are adjustments needed for the variation in the intended use environment, availability of other technologies, or operation and maintenance requirements? The discussion paper raises several questions for feedback from the industry stakeholders over the next 60 days. Although the discussion paper seems to be drafted from the perspective of conventional Class III medical devices, the issues described here also apply to Class II (510k-eligible) medical devices, particularly digital health devices, that require clinical data. The points raised are valid not just for future regulatory approval of devices in development but could also influence their reimbursement by payors as well, as the potential use of a new device by all populations is an important health economic issue for supporting paying for using it by all patients. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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