FDA impact on US medical technology innovation

Backgrounders & Fact sheets

Over the past few years, the manner in which the U.S. Food and Drug Administration (FDA) is executing its authority over the regulation of medical devices in the U.S. has been called into question. While some have claimed that current regulatory requirements are lax and harming patients, independent analysis has demonstrated that the current system does an exceptional job of protecting patients.1 However, with regard to the agency’s objective of promoting the public health through new innovations, there are increasing concerns from patients, physicians, and innovators that the FDA is falling short. Until now, little (if any) data has been produced to either validate or refute these concerns.