The AbioCor was approved under a humanitarian device exemption
. Under an HDE, the device has to show a "probable benefit," a less onerous standard than would be required under a premarket approval application, said Dr.
The world's first commercially available implanted device that restores bladder function to people with spinal-cord injuries (SCI) was approved for marketing by the Food and Drug Administration (FDA) under the Humanitarian Device Exemption
Reportedly, these products have already received regulatory approvals on all major markets and were previously sold on the US market under an HDE (Humanitarian Device Exemption
) that entailed certain restrictions.
The therapy currently is approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Ihrkinson's disease and chronic intractable primary dystonia, for which approval in the United States is under a humanitarian device exemption
InVivo was expecting to file for a humanitarian device exemption
(HDE) on data from the pilot trial, enabling it to commercialize the scaffold in the United States by around mid-2015.
In addition to reviewing the use of artificial hearts as bridge to transplantation as requested by SynCardia, CMS will review other indications for which artificial hearts are currently on the market, through a humanitarian device exemption
. Therefore, CMS initiates this national coverage analysis for the artificial heart when used for bridge to heart transplantation and for destination therapy.
Biomedical engineer Eric Chen, the FDA's lead reviewer, asserted that the device met the humanitarian device exemption
's requisite standards for biocompatibility, electrical safety, and manufacturing, but he said there are still concerns about reliability.
The device was granted a humanitarian device exemption
(for approval of a device for conditions affecting less than 4,000 people a year).
Medical technology company BIOTRONIK reported on Friday the receipt of US FDA approval for the PK Papyrus covered coronary stent system under Humanitarian Device Exemption
for use in the emergency treatment of acute coronary perforations.
stents have been approved for use in the US under Humanitarian Device Exemption
(HDE) and following the PMA approval, the stents may potentially be used to treat an increased number of patients.