Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
Posted 02 March 2012
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
Tags: Premarket Approval Process, aneurysm, Latest News, approval