CDRH issues discussion paper exploring health equity for medical devices
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has issued a discussion paper soliciting feedback on the best approaches for promoting health equity in medical device clinical studies.“Given the diversity of the US population, medical device clinical studies should adequately represent the population that is intended to use the device so that the information generated from the study can provide an understanding of device performance across populations,” states the paper.
The paper was developed as part of FDA’s strategic priorities for 2022-2025 to facilitate availability of and access to medical technologies for all populations, and complements a draft guidance issued in April on diversity in clinical research. (RELATED: FDA issues diversity action plan draft guidance, Regulatory Focus 26 June 2024)
FDA describes three factors that may help promote health equity in studies that adequately reflect the intended use population for a particular medical device.
These factors include:
- Evaluating how the burden of the disease or condition under study varies across the intended use population. FDA said this factor “may allow sponsors to better understand the extent to which certain factors (e.g., demographics, socioeconomic status, comorbidities, access to care) might influence the prevalence, incidence, and severity of a disease or condition.”
- Understanding how the etiology, progression, and prognosis of a disease or condition under study varies across the US intended use population based on physiology, anatomy, and pathophysiology. The agency said that “variation in these elements across the US intended use population may be important to understanding potential differences in device performance and may help identify mechanisms or potential causes for those differences.”
- Evaluating how the device technology may introduce, exacerbate, or mitigate the potential for different outcomes across the study population. The agency said that “it is important for FDA to understand whether the technology may operate differently in different populations within the intended use.”
FDA said these considerations may overlap, and information from an assessment of a device’s technology may inform evaluation related to disease progression. The agency “believes that utilizing a synthesis of information from these three considerations may provide sponsors with a comprehensive understanding of aspects of the study question that may affect clinical outcomes or device performance.”
FDA said that sponsors that have incorporated these considerations “may be better able to determine whether or not differences in outcomes are expected between patient populations.”
The agency is interested in whether additional factors should be considered as sponsors identify a target population to address a clinical research question.
The paper also includes a table that addresses whether a clinical study adequately reflects the intended use population.
The deadline for submitting comments is 4 October 2024. Comments should be submitted to Docket No. FDA-2024-N-3616
Discussion paper
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