Understanding Barriers to Medical Device Quality

This report is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) as part of an effort to assess and understand gaps in medical device quality. The work focuses on marketed product quality assurance, rather than pre-market activities. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.