Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. New devices offer more opportunities to improve health than at any time. Last year, the FDA approved a record number of novel devices. This reflects an advancing pace of innovation that’s resulting in many more potentially lifesaving new medical products. This includes the first artificial pancreas and the first blood test to evaluate traumatic brain injury.

The FDA plays a crucial role in the efficient development of these technologies. My colleagues in the FDA’s Center for Devices and Radiological Health (CDRH), led by Dr. Jeffrey Shuren, have been advancing new policies to drive innovation in medical product development by taking novel approaches to regulation, including the use of real world evidence to support iterative improvements in device performance and establishing a balanced framework for digital health devices that improves the lives of patients.

Although medical devices provide great benefits to patients, they also present risks. And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.
Under Dr. Shuren’s leadership, the FDA has undertaken several important initiatives to prioritize and enhance our approach to medical device safety. We’re considering what more we can do inside the FDA to better protect patients, while at the same time working closely with patients, providers, and device developers to better understand and address device risk and make sure that we’re appropriately balancing risk and benefit. I believe that the work in this area has made dramatic differences to the millions of Americans whose lives have been saved or vastly improved by these technologies.

Building on these substantial efforts, today the FDA is releasing the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. This new Action Plan outlines our vision for how the FDA can continue to enhance our programs and processes to assure the safety of medical devices. Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.

Specifically, this plan focuses on five key areas:

Establish a robust medical device patient safety net in the U.S.;

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