NYSDA Publications

FDA Seeks Public Input on Medical/Dental Device Equity

Aug 5, 2024

Per the notice below, the United States Food and Drug Administration (FDA) is seeking public input on health equity in medical/dental devices.

U.S. Food and Drug Administration, Center for Devices and Radiological Health

CDRH Seeks Your Feedback Related to Health Equity For Medical Devices

To obtain feedback about ways to help ensure that all patients have timely access to safe, effective, and high-quality medical devices and safe radiation-emitting products, the FDA’s Center for Devices and Radiological Health (CDRH) released Discussion Paper: Health Equity For Medical Devices. Graphic for Discussion Paper: Health Equity for Medical Devices

This 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.  Consistent with CDRH’s 2022 to 2025 Strategic Priority to advance health equity, this paper is intended to spur discussions about reducing barriers to achieving health equity and strategies that may help improve outcomes across diverse populations. 

Submit your comments

We want to hear from you.  Please submit comments under docket number FDA-2024-N-3616 at: https://www.regulations.gov by October 4, 2024.

Questions?

If you have questions about this discussion paper, please contact cdrhhealthequity@fda.hhs.gov.