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Originally published May 30 2009

FDA Covertly Drops Inspection of Medical Device Labs

by David Gutierrez, staff writer

(NaturalNews) The FDA has, without officially announcing any change in procedure, basically dropped the practice of inspecting the labs that carry out the first wave of tests on new medical devices, according to a report by the nonprofit organization The Project on Government Oversight.

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

The inspections in question are those carried out at labs that conduct the earliest tests on new medical devices, a category that includes internal devices such as stents, external devices such as breast pumps, and diagnostic devices such as thermometers and magnetic imaging machines. While all devices must eventually be tested on humans before receiving FDA approval, they must also undergo a battery of other tests before they get to that stage.

According to documents reviewed by the project, the FDA conducted 33 inspections of these early testing labs in 2005, seven in 2007 and one in 2008. None are schedule for 2009.

The purpose of inspections is to ascertain that a lab is complying with the FDA's standards for "good laboratory practices." The rules were implemented in the 1970s after a scandal in which a major medical lab falsified data that it presented to the U.S. government.

Documents reviewed by the Project on Government Oversight suggest that the FDA made the internal decision to scale back lab inspections in 2006, over the objections of its scientists.

"A decision of this magnitude by top officials should have been made openly, perhaps on the FDA's Web site, where it could be seen and criticized, [not] behind closed doors," said Ned Feder of the oversight project.

The division of the FDA responsible for inspecting medical devices, the Center for Devices and Radiological Health, was in the news recently when several of its own scientists complained that managers suppressed opposition and abandoned science in order to approve devices faster.

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