FDA sets out to better monitor medical devices

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CDRH (Center For Devices and Radiological Health), a part of the U.S. Food and Drug Administration, is endeavoring to increase its ability to track post-market information on approved medical devices and the ways in which it can "identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products," according to a statement on the organization's website.

In 2005, CDRH took an inventory of all of its post-market medical device safety programs, and has now developed the following goals to strengthen its efforts in the area, by:

  • Developing what it calls a 'culture of collaboration' for post-market safety within CDRH;
  • Developing world-class data sources and systems to quickly and accurately collect, analyze, and disseminate information about potential risks;
  • Enhancing risk communication efforts; and
  • Improving coordination with the FDA field staff.

The organization also said it plans to put in place a team of CDRH management and outside consultants experienced in medical device safety and product regulation to guide the effort.

Full details are available here: http://www.fda.gov/cdrh/postmarket/mdpi.html