Non-profit group criticizes FDA for ignoring GLPs
Device Regulation Alert: Safety, Compliance and Reimbursement News, February 23, 2009
The FDA is putting patient lives at risk by failing to enforce good laboratory standards (GLPs), according to the Project on Government Oversight’s (POGO) recent report, The FDA’s Deadly Gamble with the Safety of Medical Devices.
GLPs impose specific requirements for non-clinical testing of medical devices. Before the FDA approves a device as safe and effective, the manufacturer must meet GLP requirements. However, in August 2006, the FDA decided to ignore GLPs, according to POGO.
Read more about POGO's criticism of the FDA.
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