FDA Accused Of Scaling Back Quality Regulations For Medical Devices
Posted on: Wednesday, 18 February 2009, 14:56 CST
The Project on Government Oversight, an independent watchdog group, is claiming that the government has quietly scaled back enforcement of federal quality regulations at labs that develop medical devices, the Associated Press reported.
The group said that the Food and Drug Administration has dramatically reduced inspections of "good laboratory practices" at facilities that do the earliest testing of medical devices.
A report the group released on Wednesday said such inspections declined from 33 in 2005, to seven in 2007, to just one last year. The report also said that no inspections are planned for this year.
The group has taken issue with the government’s monitoring of initial testing over a wide range of medical devices before they are used on humans.
The oversight project, a nonpartisan group that exposes problems in government, said in its report that the “decision to not enforce lab standards is stunning in its contempt for the protection of patients.”
An FDA division called the Center for Devices and Radiological Health oversees the majority of medical devices, but has been shaken by recent complaints from its own scientists claiming managers downplayed debate, leading to the approval of devices that were of questionable effectiveness and perhaps not entirely safe.
A 2006 internal FDA memo released by the oversight group detailed how scientists argued unsuccessfully for continued enforcement of the lab standards. It seems that many of the scientists involved questioned the decision to scale back inspections.
Ned Feder, a staff scientist with the oversight project, said a decision of that magnitude by top officials should have been made openly, perhaps even on the FDA's Web site, where it could be seen and criticized.
"It should not be made behind closed doors," he added.
Experts say it still isn’t clear whether the relaxed enforcement resulted in harm to patients.
The FDA said manufacturers are still required to abide by the lab standards, and must certify in writing that they do so. But critics say the FDA's new policy sends a message that undermines quality in medical research.
The Society of Quality Assurance said in a letter to Congress that the decision may result in an irreversible cascade of adverse consequences to the protection of the public.
The group even posed the question: how can the first human subjects testing a new medical device be assured that the prototype was developed under the highest standards?
The FDA said its standards provide detailed specifications for running a high-quality lab. The specifications were written into federal regulation in the 1970s, after a leading medical lab was found to have fabricated data later submitted to the government.
The administration added that it could make better use of its scarce resources - and still protect the public - by focusing its enforcement on clinical trials that involve human test subjects, and not on early lab experiments.
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On the Net:
- Project on Government Oversight
- FDA
- Center for Devices and Radiological Health
- Society of Quality Assurance
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