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...consumers devices that fail work properly or are likely to be misused in ways that may cause injury or death.

Medical devices range from surgical sutures and blood glucose monitors to pacemakers and prosthetic heart valves. Regulating medical devices--from evaluating them for safety and effectiveness before they are marketed, to ensuring their continued safety and effectiveness throughout their lifetime of use--is the responsibility of the FDA's Center for Devices and Radiological Health (CDRH).

Since the enactment of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the CDRH has directed a nationwide system called postmarket surveillance to monitor the performance of marketed medical devices. But today's medical devices are vastly different from those used 30 years ago. "The medical device industry is a very rapidly growing, rapidly changing industry," says CDRH Director Daniel Schultz, M.D. "The postmarket system that we set up 30 years ago is not designed to deal with all of the new things that are happening today in the device industry."

To respond to the growing and changing industry so it can better protect public health, the CDRH has launched the Medical Device Postmarket Transformation Initiative. This new program will allow the FDA to identify, analyze, and act on problems with medical devices more quickly, including alerting the public sooner of potential problems.

"With this initiative, we're going to improve the way we monitor the safety of medical devices and provide a stronger safety net to protect public health," says Schultz.

The CDRH undertook the initiative after completing a yearlong inventory in 2005 of the tools it uses to monitor medical device safety. The inventory identified many areas that are working well, says Schultz, but it also identified areas...

NOTE: All illustrations and photos have been removed from this article.



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