Industry Supports Device Development Tools, But Says: Show Me The Money-thegraysheet: FDA presented its ideas for the program and sought comments in a November 2013 draft guidance. As the agency sees it, the medical device development tools program would speed the development and approval of new devices by creating a process for FDA to qualify sponsor-created tools and make them available for free to any other device developer. By tools, FDA means clinical outcome assessments, such as patient-reported or physician-reported rating scales; tests for detecting biomarkers; and in vitro, animal or computational models.
