As part of a program to promote medical device innovation, the FDA has qualified its first medical device development —a patient survey that could lead to advances in improving quality of life among patients with heart failure.

Qualifying these tools is a different process than what the FDA uses to approve medical devices. The tools are intended to help developers create more effective devices more quickly with less use of animals, shorter testing duration, or improved patient selection methods for clinical studies. By qualifying the tools, the FDA determines that they reliably measure the patient perceptions or outcomes, biomarkers, or device capabilities for which they were designed.