Healthcare IT News August 12, 2024
The Center for Devices and Radiological Health says a new medical device discussion paper aims to spur conversation about reducing barriers and improving outcomes across diverse populations.
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is asking the public to consider disease burden, technology and other factors in the design of clinical studies that adequately reflect the intended use population for a particular medical device.
WHY IT MATTERS
As part of CDRH’s 2022 to 2025 Strategic Priority: Advancing Health Equity, the agency said it is committed to facilitating the availability of and access to medical technologies for all populations, according to its August 5 announcement.
The agency said the goals of its discussion paper, Health Equity...