Devices

CDRH Health Equity Discussion Paper

CDRH has published a discussion paper on health equity for medical devices to solicit public input on the issue. In the paper, the Center describes factors and considerations that may be important for sponsors and other relevant parties as they develop medical device clinical studies. Specifically, it says, the paper requests 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.

The paper:

discusses three considerations (disease burden or condition; physiology, anatomy, and pathophysiology; and technology) that may help inform the 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; and
poses key questions to facilitate public feedback.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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