humanitarian device exemption

(redirected from HDE.)

humanitarian device exemption

(hu-man?i-ter'e-an),

HDE.

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
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References in periodicals archive ?
In Germany, online shopping made up 10.5 percent of total sales in 2017, according to trade association HDE. Fashion and consumer electronics account for around 50 percent of online turnover.
DBS therapy also is approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and Australia, and in the United States under an HDE.
Initialization: set related parameters (CR, F, and NP) for HDE. Set the lower bound ([k.sup.LB.sub.i]) and the upper bound ([k.sup.UB.sub.i]) of [k.sub.i] respectively.
Researchers at Boston University School of Medicine (BUSM) revealed that exposure to both HDE and DEP showed increased mucus production and higher airway resistance compared to exposure to only HDE.
The FDA issued a warning letter to Stryker's Biotech unit last year involving issues that included the falsification of hospital-approval documents used under the HDE.
The company estimates that up to 1,500 children per year could benefit from the technology if it is successful in getting the HDE.
The CARS IDE will provide continued PFO closure access to certain patients who previously were eligible for treatment under the HDE. However, while patients in the CLOSURE I trial receive the implant at no cost, those covered under the CARS IDE can be charged for the device.
We chose to examine performance in ice hockey for this reason and also because it would enable us to assess the merits of a modified version of Baumeister and Steinhilber's account of the HDE.
In order to improve convergence, the local search routine and adaptive crossover operator are applied in HDE.
Fourteen out of the 15 patients have been enrolled in the trial thus far, and the FDA does not require the 15th to be enrolled before Abiomed can apply for approval under an HDE.