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An exception was carved out for new versions of high-risk devices already on the market.
Manufacturers could get approval by convincing the FDA that these devices were "substantially equivalent" to their precursors. In 1990, Congress ordered the FDA to end the practice, but it has continued even as generations of technology have come and gone.
The report urged the FDA to promptly resolve the problem, either by carrying out full reviews or reclassifying some devices as lower risk, if appropriate.
The FDA acknowledged the problem, but has not set a timetable for resolving it. "In general, we agree with the conclusions and recommendations," said spokeswoman Karen Riley. "We are considering legal and procedural options to accomplish this objective."
The GAO report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers.
"It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," said Peter Lurie, deputy director of Public Citizen's health research group.
On the Net:
GAO report: http://tinyurl.com/73nyhl
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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