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FDA lax on medical device safety, report says

February 26, 2009 by  

Report claims that FDA has poor oversight of quality standards at laboratories which develop medical devicesA non-profit organization has released a report which details the FDA’s alleged lack of oversight of quality standards at laboratories which develop medical devices.

The FDA’s Deadly Gamble with the Safety of Medical Devices report was released by the Project on Government Oversight on February 18, and singles out the Center for Devices and Radiological Health (CDRH), a part of FDA, as the main culprit.

In particular, the report alleges that senior CDRH officials have not been enforcing the Good Laboratory Practice (GLP) regulation from 1979 that prohibits manufacturers from setting their own standards of laboratory testing. As a result, manufacturers are free to monitor their own compliance with the regulation.

"There are many insiders who are deeply concerned that real harm is being done," says Danielle Brian, executive director of POGO, adding "Such a decision affecting public health should not have been made behind closed doors."

In conclusion, the organization recommends that Congress or the Department of Health and Human Services investigate the FDA officials’ decision to ignore the GLP regulation and audit records that contain evidence of manufactures’ compliance with the regulation.

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