Introduction
Innovation is a main driver of every industry. This is especially true for medical device companies which, in conjunction with surgeons, are inventing, developing, and commercializing technologies to improve clinical outcomes for patients worldwide. With over 6,500 medical device companies in the United States alone, the global device market is expected to reach $543.9 billion by 2020. This growth, driven by an aging population, increasing healthcare expenditure and technology advancement, will drive the Food and Drug Administration (FDA) to review an ever-increasing number of device applications.
The speed with which a new medical device can be brought to market is greatly influenced by the resources available to the FDA. As such, the FY2018 Presidential Budget Request (PBR) aims to continue the trajectory of innovation by increasing the number of reviewers, in order to streamline the process of submission review. It attempts to accomplish this task through a restructuring of the funding sources for reviewers while maintaining the same threshold of review quality and least burdensome practices.
Analysis by Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) of ...
