humanitarian device exemption

Also found in: Acronyms.

humanitarian device exemption



Legal permission from the FDA to a manufacturer of a new medical device granting it a waiver from some of the usual requirements in order to expedite introduction of the device into clinical use. HDEs are granted for devices that treat rare diseases for which it would be impractical or economically unfeasible to test the device thoroughly before use. Synonym: humanitarian use device
References in periodicals archive ?
The Company expects that the FDA will require five patients for the pilot study and that the product will be regulated under a Humanitarian Device Exemption pathway, both factors that InVivo believes will accelerate product commercialization.
At present, OP 1 products only are approved under a humanitarian device exemption (HDE) for limited use in trauma situations and spinal surgery.
Danvers, MA, has submitted an application to the US Food and Drug Administration (FDA) for market approval of its AbioCor Implantable Replacement Heart under a Humanitarian Device Exemption (HDE).
If the HUD application is designated by the FDA, Aethlon may then submit a Humanitarian Device Exemption (HDE) marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review.
S Food and Drug Administration under a Humanitarian Device Exemption (HDE).
This is due mainly to our voluntary withdrawal of the Humanitarian Device Exemption of our CardioSEAT septal repair implant.
The FDA's Center for Devices and Radiological Health (CDRH) on February 25 approved a Humanitarian Device Exemption (HDE) for use of the miniaturized heart pump for children aged 5 to 16.
Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has been scheduled to review the data presented in the company's Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis) on September 28, 2012 in Gaithersburg, Maryland.
The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the eTNS system.
The Center for Devices and Radiological Health (CDRH) has approved Humanitarian Device Exemption (HDLE) for use of a heart assist device as an aid in determining why a transplanted heart has rejected.
The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.
Minneapolis, MN, announced it has received a Humanitarian Device Exemption (HDE) from the FDA to market a bioprosthetic valved conduit to correct congenital defects of the right side of the heart in children.

Full browser ?