In 1996, the FDA established the humanitarian device exemption, or HDE, for medical devices. Companies could gain FDA approval through the exemption by simply showing their product provided a benefit to patients. The FDA only grants these exemptions to devices that treat conditions affecting fewer than 4,000 people a year.
It's fast and it's saving lives. In the past 15 years, 50 medical devices have been sold and used under the HDE provision.
One of the most recent is a device called the BSD-2000. It was approved for women with cervical cancer who are too sick for chemotherapy.
The device uses microwaves to heat the body up to 104 degrees to kill cancer cells. Despite its development in the 1980s, the device has yet to gain medical acceptance or full FDA approval.
The most recent approval is for the Liposorber LA-15 system.
The device treats children with primary focal segmental glomerulosclerosis, called FSGS, a chronic condition where scar tissue blocks filters in the kidneys and can cause blood to lose protein. FSGS is the second leading cause of kidney failure in children.
The system removes blood, separates the plasma, and then absorbs lipoproteins, which can worsen the disease. The treated plasma and blood are then returned to the body.
The FDA allows companies to sell these exempt devices for profit. Critics of the process say it puts untested devices into the medical community and companies can use it as a loophole to get their product to market faster.