FDA Updates Breakthrough Devices Guidance To Improve Health Equity

The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.

Health Disparities — • Source: Shutterstock

The Food and Drug Administration’s updated final guidance on breakthrough devices seeks to clarify components of the program related to reducing inequities in healthcare.

The updated document, dated 15 September, supersedes draft guidance the agency issued in October 2022, “Select Updates for...