FDA Clears First Medical Device Development Tool

A clinical outcome assessment questionnaire for measuring health outcomes reported by patients with congestive heart failure or weakened heart muscle became the first FDA-qualified medical device development tool.

Patients’ answers to the Kansas City Cardiomyopathy Questionnaire can be used in a benefit-risk assessment to support new device submissions and post-approval studies, CDRH Director Jeffrey Shuren said in a blog post with Hilda Scharen, CDRH’s director of medical device development tools.

The questionnaire includes 23 inquiries for patients’ about their perceived health status, including the impact of heart failure symptoms on quality of life, as well as physical and social limitations.

The FDA’s voluntary Medical Device Development Tools program is intended to facilitate finding measuring tools proven to be accurate, efficient and reliable to help streamline regulatory review processes. It also provides a collaboration mechanism for developers and manufacturers in the development and adoption of these tools, the FDA said.