Wednesday, February 18, 2009

FDA Not Enforcing Medical Device Safety Standards

Dow Jones Newswires reports, "The Food and Drug Administration isn't enforcing quality and safety testing standards for medical devices, potentially putting patients at risk, according to a report to be released Wednesday by a nonpartisan watchdog group." Also, "the report says an official within the FDA's medical device division told an organization of researchers and scientists that many medical device companies weren't following federal quality and safety testing standards for medical devices and that requiring those standards wasn't 'feasible.'"

From McClatchy: "The Food and Drug Administration put patients' lives at risk by halting enforcement of 30-year-old requirements that medical device makers meet federal laboratory standards prior to testing their products on humans, a watchdog group charges in a new report." Also, according to the report, "at present, if a manufacturer knowingly violates the GLP regulation and falsely asserts compliance with GLP, that manufacturer is safe - safe from discovery, safe from disciplinary action by the FDA, safe from prosecution."

The AP notes that "The Project on Government Oversight found that the Food and Drug Administration has dramatically reduced inspections of 'good laboratory practices' at facilities that do the earliest testing of medical devices." The group wrote in the report, "The decision ... to not enforce (lab standards) is stunning in its contempt for the protection of patients."

Get the report HERE.

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