National Medical Device Postmarket Surveillance Plan
The mission of FDA's Center for Devices and Radiological Health (CDRH) is to protect and promote the public health by: 1) assuring that patients and providers have timely and continued access to safety, effective, and high-quality medical devices and safe radiation-emitting products; 2) providing consumers, patients, their caregivers and providers with understandable and accessible science-based information about the products we oversee; and, 3) facilitating medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
A key part of this mission is to monitor medical devices and radiological products for continued safety and effectiveness after they are in use and to help the public get the accurate, science-based information they need to improve their health.
The FDA has released two reports on our vision of a medical device postmarket surveillance system. The initial report, "Strengthening Our National System for Medical Device Postmarket Surveillance," was issued in 2012 and provides an overview of FDA's medical device postmarket authorities and the current U.S. medical device postmarket surveillance system. It proposes four specific actions, using existing resources and under current authorities, to strengthen the medical device postmarket surveillance system in the United States. The update to the report, issued in 2013, details the concrete steps that the agency will complete to more efficiently collect better and more timely data, helping to identify issues more quickly. In 2015, the Engelberg Center for Health Care Reform issued a new report titled, “Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System.” The report outlines key steps to create a multi-stakeholder system that can support the development, regulation, and effective use of medical devices, while supporting improvements in patient safety and health outcomes.
Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System(PDF - 1.2MB) Strengthening Our National System for Medical Device Postmarket Surveillance(PDF - 403KB) Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps - April 2013(PDF - 289KB) Device Postmarket Surveillance