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FDA Has Reduced Enforcement Of Standards For Medical Device Laboratories,


FDA Has Reduced Enforcement Of Standards For Medical Device Laboratories, Report Finds (Medical News Today)
The Center for Devices and Radiological Health at FDA in recent years has reduced enforcement of "good laboratory practices" for facilities that develop medical devices, according to a report released on Wednesday by the Project on Government Oversight, the AP/Kansas City Star reports.

Too few FDA tests of high-risk devices, activists say (Reuters via Yahoo! News)
The Project on Government Oversight (POGO) called on Wednesday for an investigation into the U.S. Food and Drug Administration's early laboratory inspections of high-risk medical devices, faulting the agency for conducting too few.

Cardinal Health, US FDA amend infusion pump consent decree (PharmaBiz)
Cardinal Health has reached an agreement with the Food and Drug Administration (FDA) on an amended consent decree regarding the company's infusion pump products.
 

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