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…