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 less than 4,000 people a year.
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 BSD2000. It was approved for women with cervical cancer who are too sick for chemo.
The device uses microwaves to heat the body up to 104 degrees to kill cancer cells. Despite its development in the 1980's, 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 lipo-proteins, 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.
TOPIC: FAST TRACK FOR FAST FDA APPROVAL
REPORT: MB #3725
FDA EXEMPTION: A 501(k) exempt is immunity from the FDA review of medical devices before they are marketed to medical care professionals. These devices can be exempt due to the low risk they have and if they have completed the online listing through the FDA Unified Registration and Listing System, FURLS. However, these devices are not exempt from general controls. The devices must be packaged properly, suitable for intended use, manufactured under a quality system, and they must have an established registration and device listing forms with the FDA. (Source: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm)
BSD-2000: The BSD-2000 Hyperthermia System is a machine created for the use of patients who have cervical cancer. This system is used in conjunction with radiation therapy for those who are not well enough to have chemotherapy treatments. This will increase the reply of the tumor cells to radiation therapy. The system works by microwaving the tumors to heat them up until they "cook" themselves away. This system is not suitable for all patients. Those who have heart or lung dysfunction, high or low blood pressure, other implanted devices, and cerebrovascular disease should not use this system. (Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm286404.htm)
LIPOSORBER LA-15 SYSTEM: This system was recently approved by the FDA and is used to treat the chronic disease focal segmental glomerulosclerosis (FSGS). This disease is common in children before or after kidney transplantation. The Liposorber LA-15 System works to process the blood outside of the body while removing lipoproteins from the blood of the patient. (Source: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm370931.htm
HDE PROVISION: The Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 adults in the U.S. each year. To gain approval of an HUD, a humanitarian device exemplification (HDE) application is to be submitted to the FDA. Under the HDE, a device does not have to be approved by the FDA to be marketed, but it must meet requirements to show the FDA that the device will not pose a threat to users. The applicant must provide satisfactory information regarding the product and it must be safe to use. The application must also state how the device will diagnose or treat the condition. (Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/)
FOR MORE INFORMATION, PLEASE CONTACT:
US Food and Drug Administration