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Mike Mitka

JAMA. 2006;295:1109-1110.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The US Food and Drug Administration (FDA) announced it has initiated a process aimed at improving patient safety through better postmarketing oversight of medical devices—an action that comes in the midst of some high-profile reports of recall notices, subpoenas, and corporate warning letters about problematic cardiac devices.

At a January 20 press conference, the FDA's Center for Devices and Radiological Health launched an initiative to improve safety monitoring of medical devices after they reach the market, by creating a regulatory environment that enables investigators to move more quickly to identify, analyze, and act when medical device problems surface. Daniel Schultz, MD, the center's director, said the announcement came after about one year's work.

After recent recalls of implantable cardiac aids, federal health officials announced an effort to improve safety monitoring of medical devices. (Photo credit: Guidant Corporation)

"We decided that it was time to . . . take a more comprehensive look . . . [Full Text of this Article]

CHRONOLOGY OF CONCERN

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