Health & Medicine
FDA Does Not Properly Regulate Medical Devices, Report Reveals
Kathleen Lees
First Posted: Oct 06, 2014 01:07 AM EDT
Recent findings published in JAMA Internal Medicine show that the Food and Drug Administration (FDA) doesn't always do the best job regulating medical devices.
The first study examined 510(k), which is an approval pathway for devices that was created in 1976-which determines whether or not diagnostic tests, heart valves, surgical machines or other risky devices can be marketed by looking at scientific data.
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.
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.
A second study by researchers at the Pew Charitable Trusts looked at how an FDA program works to track the safety of high-risk medical devices, such as defibrillators and heart stints.
Unfortunately, findings revealed that these devices are not properly monitored by the FDA.
Furthermore, since 2005 to 2011, the FDA has only removed one of these devices from the market and ordered label changes to 31 others. Unfortunately, many health officials do not think this will be enough.
"Label changes aren't going to do anything to protect anybody," concluded cardiac surgeon Hooman Noorchashm of Thomas Jefferson University in Philadelphia. "It's just another layer of informed consent."
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First Posted: Oct 06, 2014 01:07 AM EDT
Recent findings published in JAMA Internal Medicine show that the Food and Drug Administration (FDA) doesn't always do the best job regulating medical devices.
The first study examined 510(k), which is an approval pathway for devices that was created in 1976-which determines whether or not diagnostic tests, heart valves, surgical machines or other risky devices can be marketed by looking at scientific data.
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.
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.
A second study by researchers at the Pew Charitable Trusts looked at how an FDA program works to track the safety of high-risk medical devices, such as defibrillators and heart stints.
Unfortunately, findings revealed that these devices are not properly monitored by the FDA.
Furthermore, since 2005 to 2011, the FDA has only removed one of these devices from the market and ordered label changes to 31 others. Unfortunately, many health officials do not think this will be enough.
"Label changes aren't going to do anything to protect anybody," concluded cardiac surgeon Hooman Noorchashm of Thomas Jefferson University in Philadelphia. "It's just another layer of informed consent."
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone