Regulatory Focus™ > News Articles > Coalition Protests Aneurysms Treatment Device Approval

Coalition Protests Aneurysms Treatment Device Approval

Posted 02 March 2012 | By

A patient safety coalition is asking the US Food and Drug Administration (FDA) for more testing into a device that treats complications from aneurysms treatments.

According to a report by Qmed, a letter was sent to FDA commissioner Margaret Hamburg urging that the device, the endovascular suturing system, should have been classified as high risk and subjected to more rigorous testing. FDA granted approval after a study involving 10 women and 144 men under the de novo process, which is intended for low and moderate risk medical devices.

The letter asks FDA to rescind the approval and review it using the more rigorous Premarket Approval Process.

FDA has been criticized because many medical devices have been recalled as potentially lethal after having been approved by FDA without scientific clinical trials proving that the devices were safe or effective, according to Qmed.

Read more:
Qmed - Patient Safety Coalition Protests FDA's Approval Of Device Used For Treating Aneurysms


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