Call Us - We're Easy to Talk To (214) 999-9999

Report Says FDA Is Not Enforcing Medical Device Safety Standards

Dow Jones Newswires (2/18, Favole) 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.'”

McClatchy (2/18, Gordon) reports, “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 (2/18, Alonso-Zaldivar) reports, “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.”

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

If you find this type of information interesting or helpful, please visit my law firm's main website at You will find many more articles and links. Thank you for your time.

Find us on your preferred network