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Report: FDA Dropped Early Medical Device Lab Inspections
June 8, 2009
Medical Report Outsourcing (Blog)
A report released by nonprofit group The Project On Government Oversight (POGO) has found that the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has failed to carry out lab inspections of medical devices at the earliest stages. “The FDA’s Deadly Gamble with the Safety of Medical Devices” states the result of not following Good Laboratory Practice (GLP) is putting patients’ lives at risk. “There are many insiders who are deeply concerned that real harm is being done.Such a decision affecting public health should not have been made behind closed doors,” said Danielle Brian, executive director of POGO....
The inspections in question by the Washington, D.C.-based nonprofit organization that investigates corruption are those in 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.
