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Studies Report: FDA does not Properly Regulate Medical Devices

Update Date: Oct 03, 2014 03:34 PM EDT

Two new studies are reporting that the Food and Drug Administration (FDA) does a poor job at regulating medical devices. The researchers concluded that in order to make sure that these devices are safe for the public, the FDA must make changes.

In the first study, the researchers examined 510(k), which is an approval pathway for devices that was created in 1976. The 510(k) determines whether or not diagnostic tests, surgical machines, heart valves and other risky devices can be marketed. The process looks at scientific evidence that has to be submitted for each device.

The researchers from the National Center for Health Research found that only eight of the 50 implantable devices that were recently marketed after getting approval under the FDA's 510(k) had been submitted with scientific evidence.

"Despite the legal requirement that scientific evidence of substantial equivalence be publicly available ... such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates," the authors concluded according to Medical Xpress.

The team and other groups, such as the Institute of Medicine and Public Citizen, have been calling for a replacement of the 501(k) system.

In the second study, researchers from the Pew Charitable Trusts examined how an FDA program tracks the safety of high-risk medical devices. These types of devices, such as heart stents and defibrillators, often have to go through a stricter approval process. The team found that even though the FDA does monitor these devices, the studies that the agency ordered were too small to effectively evaluate safety.

From 2005 to 2011, the FDA had ordered 223 post-approval studies for 158 high-risk tools. In response to the concerns about these items and the small studies, the FDA had only one device removed from the market. For another 31 devices, the FDA ordered changes to their labeling.

"Label changes aren't going to do anything to protect anybody," commented cardiac surgeon Hooman Noorchashm of Thomas Jefferson University in Philadelphia. "It's just another layer of informed consent."

The studies noted that the FDA is in the process of changing the approval system for the better. Both studies were published in JAMA Internal Medicine.

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