Recently, existence of solutions to some classes of HDEs
is studied with the use ofhybrid fixed point theory (see [14-18]).
The company said the next step is for the FDA to approve a Humanitarian Device Exemption (HDE
) application for each indication of the 50cc TAH.
Public Citizen and 13-year FDA veteran Larry Kessler, Sc.D., petitioned the FDA to pull its humanitarian device exemption (HDE) approval of the Wingspan Stent System, a device used to open blocked blood vessels in the brain.
Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH).The letter accuses Boston Scientific of using the HDE process to gain approval of Wingspan based on a clinical trial that was "not designed to demonstrate whether treatment with the device was safer or more effective than medical therapy alone." It also provides details of several studies that have been conducted since the system was cleared, though the writers acknowledge that each of the studies contain methodological weaknesses that could prevent clinicians from reaching any valid conclusions about the risks and benefits of using the Wingspan system rather than medical therapy alone to prevent strokes.
To encourage product development, the 2007 Amendments lift the restriction under the Humanitarian Device Exemptions ('HDE') on making a profit from the use of HDE-designated devices when such use is intended for paediatric patients.
The requirement to register clinical trials now applies to studies of devices approved under the 510(k), PMA, and HDE pathways.
26 January 2010 - US medical technology company Medtronic Inc (NYSE: MDT) said yesterday that its Melody Transcatheter Pulmonary Valve has obtained US Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE
One issue that arose from these meetings and the comment period was that many stakeholders felt the prohibition from generating profits for the Humanitarian Device Exemption (HDE
) served as a significant disincentive to develop products for the pediatric population.