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 is making available for public comment a preliminary report entitled "Strengthening Our National System for Medical Device Postmarket Surveillance." This report, in addition to providing an overview of FDA's medical device postmarket authorities and the current U.S. medical device postmarket surveillance system, proposes four specific actions, using existing resources and under current authorities, to strengthen the medical device postmarket surveillance system in the United States.
Comments can be made by utilizing the e-mail form below. CDRH will review each of the comments to better inform a final strategy but unfortunately, we will not be able to respond to each submitted comment.