As part of a broader effort to expand health outcomes across diverse populations in the U.S., the U.S. Food and Drug Administration (FDA) has published a Discussion Paper to facilitate a public discussion on how to advance health equity in connection with medical devices.
Published in early August by the FDA’s Center for Devices and Radiological Health (CDRH), the Discussion Paper, titled “Health Equity for Medical Devices,” outlines various factors and considerations that may be important for device manufacturers to consider in clinical studies intended to support the development of advanced and innovative medical devices.
Specifically, the paper discusses three considerations (disease burden or condition; physiology, anatomy, and pathophysiology; and technology) that may need to be considered in the design of clinical studies to adequately reflect the intended use population for a given device. The paper also addresses other aspects to consider in evaluating whether data derived from clinical studies is representative of the intended use population for a given device.
The FDA’s Discussion Paper on “Health Equity for Medical Devices” is available at https://www.fda.gov/media/180608/download?attachment. The FDA is seeking public comment on the points presented in its Discussion Paper, as well as on other relevant factors in ensuring health equity in medical device development. Comments can be submitted until October 4th through the Regulations.gov website (reference docket number FDA-2024-N-3816).
