Earlier this month, the FDA published a Discussion Paper titled “Health Equity for Medical Devices”. According to the CDC, Health Equity is “the state at which everyone has a fair and just opportunity to achieve their highest level of health.” As part of this Discussion Paper, the FDA is seeking feedback to support a potential regulatory approach regarding Health Equity. The goal, in the FDA’s words, is to work toward assuring that all patients have timely access to safe, effective, and high-quality medical devices.
In the Discussion Paper, the FDA lays out various factors that medical device companies should consider carefully in the development of clinical studies and explains how these factors may impact the FDA’s evaluation of clinical evidence. Further, the FDA explains when a device should be evaluated in diverse populations so that the clinical data intended to support a marketing submission are representative of the intended use population identified for the device. Specifically, the FDA provides three considerations that could help sponsors and investigators in the design of studies to ensure adequate representation of the intended use population:
- Disease burden or condition - How does the burden of the disease or condition under study vary across the US intended use population?
- Physiology, anatomy, and pathophysiology - How does the etiology, progression, and prognosis of a disease or condition under study vary across the US intended use population based on physiology, anatomy, and pathophysiology?
- Technology - How might the device technology introduce, exacerbate, or mitigate the potential for different outcomes across the study population?
The Discussion Paper addresses each of these three considerations in detail and solicits input on how such considerations can be incorporated into the early study design process. To enhance the discussion, the FDA provides five “Discussion Questions” that it would like stakeholders to assess which would help form the basis for development of a clinical study plan aligned to the intended use population identified for a particular medical device.
The Discussion Paper also outlines two factors that the FDA must consider when evaluating whether clinical data provided by sponsors are generalizable to, and representative of, the intended use population:
- Clinical study population - Consideration of the population included in the clinical data provided to support a premarket decision and the rationale given by the sponsor for the population.
- Differences between populations - Consideration of whether the data suggest that there are differences in outcomes between populations.
Several real-world examples are assessed throughout the Discussion Paper, and the FDA also includes a helpful table which addresses the potential relationship between clinical study data and FDA considerations.
Health Equity is garnering more and more attention within the medical device industry. The FDA recognizes the urgent public health need for innovative technologies that help to reduce barriers to achieving Health Equity and that help to improve health outcomes across diverse populations. As such, the FDA is enhancing its focus on the design of appropriate clinical studies and the use of adequate data to understand differences in outcomes between patient populations. This Discussion Paper is a critical step in that process. Stakeholders are encouraged to provide comments on the Discussion Paper no later than October 4, 2024.
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