The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has developed a discussion paper, Health Equity For Medical Devices, and seeks input from the public on advancing health equity on the context of medical devices.
About the Discussion Paper
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.
The FDA’s Center for Devices and Radiological Health (CDRH) is providing this discussion paper to receive public input on advancing health equity in the context of medical devices.
Clinical studies often play a critical role in understanding the safety and effectiveness of new medical devices in the populations that are intended to use them.
In this discussion paper, CDRH describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies and seeks feedback from the public. Specifically, the discussion paper request feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device. Consistent with CDRH’s 2022 to 2025 Strategic Priority: Advancing Health Equity, the discussion paper is intended to spur discussions about reducing barriers to achieving health equity and strategies that may help improve outcomes across diverse populations.
The discussion paper:
- Discusses three considerations (disease burden or condition; physiology, anatomy, and pathophysiology; and technology) that may help inform design of a clinical study that adequately reflects the intended use population for a particular medical device.
- Discusses two important areas of consideration when evaluating whether clinical data are generalizable to, and representative of, the intended use population identified for a particular device.
- Poses key questions to facilitate public feedback.
The FDA is seeking input on these considerations and on the related questions posed in the discussion paper.
Submitting Comments on the Discussion Paper
As part of its commitment to health equity, CDRH is sharing Discussion Paper: Health Equity For Medical Devices for public comment. The FDA encourages stakeholders to provide comments in the Federal Register under docket number FDA-2024-N-3616. The last day to submit comments is October 4, 2024.
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