The US Food and Drug Administration’s New Regulatory Toolkit to Bring Medical Device Innovation Back to the United States

The US Food and Drug Administration (FDA) is committed to promoting public health by facilitating the development of innovative medical devices so that US patients can have the earliest and broadest access to beneficial technologies. Although there has been a slight increase in the number of clinical studies conducted in the United States, this increase has not kept pace with that observed in non-US sites.¹ Because of the concern that device innovation may follow this trend, the FDA’s Center for Devices and Radiological Health (CDRH) has been focused on removing or minimizing some of the barriers that may contribute to this movement, including the ineffective communication between the FDA and industry, the insufficient predictability of the information needed to allow for the initiation of clinical studies for complex and novel device types, and the poor quality of applications being submitted to the FDA by medical device sponsors.²