Health equity champions, listen up and get ready to comment!
The FDA’s new discussion paper, “Health Equity For Medical Devices” is sparking conversations and helping build important momentum for change. We’re overdue to consider how we build clinical trial designs that prioritize diversity and inclusivity.
Key points from the paper we’re reacting to:
• How do demographics, socioeconomic status, and healthcare access impact disease prevalence and severity?
• Are outcome disparities among patient populations device-related?
• Could limited diversity in trials lead to the FDA requiring labeling that a device has demonstrated it is safe and effective for specific populations?
These questions are crucial as we work towards more equitable medical devices like our VitalO₂ device.
Take a deeper dive, you can find the full discussion paper and provide comments on the FDA’s website.