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FDA Cuts Inspections of Labs Testing Medical Devices

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Enforcement of federal quality regulations at labs that develop medical devices has been scaled back by the U.S. Food and Drug Administration, according to a Project on Government Oversight report.

The independent watchdog group found that FDA inspections of "good laboratory practices" at facilities that do early testing of medical devices such as pacemakers, stents and imaging machines declined from 33 in 2005, to seven in 2007, to one in 2008, the Associated Press reported. No FDA inspections are planned for this year.

"The decision ... to not enforce [lab standards] is stunning in its contempt for the protection of patients," the group said in its report.

By focusing its enforcement on clinical trials that involve people, and not on early medical device testing in labs, the FDA says it can make better use of scarce resources and still protect the public, the AP reported.

Critics disagree. "This decision ... may result in an irreversible cascade of adverse consequences to the protection of the public," the Society of Quality Assurance said in a letter to Congress.

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