On August 5, the FDA’s Center for Devices and Radiological Health (CDRH) released a Discussion Paper: 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 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.
