Premier Submits Comments to FDA on Proposed Health Equity Designation for Medical Devices
Premier submitted comments to the FDA on draft guidance intended to update the Breakthrough Devices Program to include certain devices that benefit populations impacted by healthcare disparities. Prior to finalizing the draft guidance, Premier urged the FDA to:
Define the data elements it intends to utilize to measure health equity in medical devices under the Breakthrough Devices Program;
Outline requirements and expectations for manufacturers granted a health equity designation to conduct real-world evidence studies to understand the practical implications of their devices on improving health equity; and Ensure the approach strikes the appropriate balance between innovation and patient access while minimizing unintended consequences such as leveraging the pathway to thwart market competition.
