The U.S. for decades has led the global medical device industry, providing life-saving and life-improving devices to patients and employing more than two million people in device-related jobs. However, the Food and Drug Administration's (FDA) unpredictable, inconsistent and non-transparent handling of the review process has threatened our nation's medical device leadership, hurting patients, American jobs, and innovation. After hearing from patients, inventors, investors and employers, committee members from both sides of the aisle introduced 10 legislative solutions to improve the predictability, consistency, and transparency of FDA's medical device review and approval process.

House Energy and Commerce Committee news release