humanitarian device exemption

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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 device was granted a humanitarian device exemption (for approval of a device for conditions affecting less than 4,000 people a year).
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption application for approval.
Cellular therapies company Vericel Corporation (NasdaqCM:VCEL) said on Tuesday that it intends to submit a Humanitarian Device Exemption (HDE) supplement to the US FDA in the Q4 2015 for Epicel to revise its labeled indications to specifically include pediatric patients.
The XPS received a Humanitarian Use Device (HUD) designation and was reviewed through the Humanitarian Device Exemption (HDE) pathway.
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).
It was approved previously under a humanitarian device exemption for use in hand reconstruction and donor sites in patients with skin loss due to epider-molysis bullosa.
US-based medical device company Torax Medical's Fenix Continence Restoration System for the treatment of fecal incontinence has received US Food and Drug Administration approval under a Humanitarian Device Exemption, the company said.
Additionally, the BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the US FDA for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy as well as CE (Conformite Europeenne) marking approval in Europe, concluded BSD Medical.
Following FDA approval in 2010 of the Melody TPV under a Humanitarian Device Exemption (HDE), the device equivalent of regulations for "orphan" drugs, the post-approval study prospectively enrolled 120 patients at 10 U.

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