Medical Devices

Improving Device Postmarket Surveillance

In September 2012, the FDA published a report, "Strengthening Our National System for Medical Device Postmarket Surveillance", which proposed a strategy for improving our current system for monitoring medical device safety and effectiveness.

FDA’s vision for an integrated national medical device postmarket surveillance system is one that:

  • Communicates timely and accurate information on the benefits and risks of medical devices throughout their marketed life using high quality, standardized, structured, electronic health-related data;
  • Identifies potential safety issues in real-time from a variety of privacy-protected data sources;
  • Reduces the burdens and costs of medical device postmarket surveillance; and
  • Facilitates the clearance and approval of new devices, or new uses of existing devices.

Following release of the report, FDA held a series of public meetings on September 10 -13, 2012 and accepted comments via our website to garner stakeholder feedback on the report.

In April 2013, the FDA issued an update to the report that incorporates public input we received and describes the next steps we are taking in the following areas to fulfill the vision for a national postmarket surveillance system:

  1. Establish a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board;
  2. Establish a unique device identification (UDI) system and promote its incorporation into electronic health information;
  3. Promote the development of national and international device registries for selected products;
  4. Modernize adverse event reporting and analysis; and
  5. Develop and use new methods for evidence generation, synthesis, and appraisal.

Page Last Updated: 06/05/2014
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