A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed...

and for Parkinson's disease since 2002. It was approved as a humanitarian device exemption for dystonia in 2003, obsessive–compulsive disorder (OCD) in...

and it received approval in the US in February 2013 under a humanitarian device exemption. The Argus II system costs about US$150,000, excluding the cost...

therapy Higher Diploma in Education Home Defence Executive Humanitarian Device Exemption German Trade Association This disambiguation page lists articles...

Additionally, gastric electrical stimulation (GES; approved on a humanitarian device exemption) can be used as treatment. Nutrition may be managed variously...

retrieved 2023-04-23 Health, Center for Devices and Radiological (2022-10-03). "Humanitarian Device Exemption". FDA. Retrieved 2023-04-23. Regulation...

first time since his accident. In 2008, the device was approved by the FDA under a Humanitarian Device Exemption, and received premarket approval in 2023...

transplant is the only other option. They were approved under the Humanitarian Device Exemption, which means the manufacturer did not have to demonstrate effectiveness...

medical transport. In January 2015, the Impella RP was granted a humanitarian device exemption to provide circulatory assistance for patients with right heart...

A ventricular assist device (VAD) is an electromechanical device that provides support for cardiac pump function, which is used either to partially or...

approved deep brain stimulation for the treatment of OCD under a humanitarian device exemption, requiring that the procedure be performed only in a hospital...

transplantation. Though the device was initially rejected by FDA Circulatory System Devices Panel in 2005 for Humanitarian Device Exemption (HDE) status, it was...

Biotech) for a humanitarian device exemption as an alternative to autograft in long bone nonunions. In 2004, the humanitarian device exemption was extended...

stimulate contraction". The marketed NeuRx device received several FDA approvals under a Humanitarian Device Exemption (HDE), one in 2008 and another in 2011...

approved PyroCarbon interphalangeal joint replacements under the Humanitarian Device Exemption. Ratner, Buddy D. (2004). Pyrolytic carbon. In Biomaterials...

approved in Europe in 2006 and in the U.S. in 2010 under a Humanitarian Device Exemption (HDE), is designed to treat congenital heart disease patients...

a humanitarian device exemption, an application for premarket approval of a medical device, or a product development protocol for a medical device to...

with glasses or contact lenses. They were approved under the Humanitarian Device Exemption, which means the manufacturer did not have to demonstrate effectiveness...

Specific Talus Spacer through the humanitarian device exemption (HDE) process. A Humanitarian Use Device (HUD) is a device that is intended to benefit people...

essential tremor, in 2002 for Parkinson's disease, and received a humanitarian device exemption from the FDA in 2003 for motor symptoms of dystonia. It was...

for medical devices that have been granted humanitarian device exemptions to include devices intended for use in adults, if such a device is intended...

Theraspheres (glass 90Y microspheres) are FDA approved under a humanitarian device exemption for hepatocellular carcinoma (HCC). SIR-spheres (resin 90Y microspheres)...

to fusion for a small number of patients through the FDA's humanitarian device exemption (HDE) pathway.[failed verification] Most patients are eventually...

self-determination of all matters relating to her body, and the withdrawal of the exemption or defence of marital rape. Most countries criminalized marital rape from...

Medical Devices Act (SMDA), which authorized the FDA to recall devices that pose a risk to patient safety and created the Humanitarian Use Device program...

BiVACOR heart received FDA authorization under the investigational device exemption for use in human trials. In July 2024, a successful implantation of...

hospitals to support safe surgery throughout Ukraine since receiving Humanitarian Exemption from the Ukrainian government. MIT Technology Review 35 Innovators...

Strait (part of Queensland, Australia) for traditional purposes. This exemption from passport control is part of a treaty between Australia and Papua...

whether applied by civilian or military agents." GCIV provides an important exemption: Where in the territory of a Party to the conflict, the latter is satisfied...

workers making less than $16.50 an hour. In December 2015, Hawley supported exemptions for Missouri "businesses and religious groups from participating in same-sex...