MDUFA III

MDUFA III, or the Medical Device User Fee Amendments of 2017, is an agreement between the FDA and the medical device industry. It authorizes the FDA to collect fees from device companies to fund the review and approval process of new medical devices. The goal is to streamline and enhance the efficiency, safety, and timely availability of innovative medical devices to healthcare providers and patients. MDUFA III set specific performance goals for the FDA, such as reducing approval times, ensuring thorough reviews, and maintaining high safety standards, all while balancing industry needs with public health priorities.