Healthy Living: Fast Track To FDA Approval
In 1996, the Food and Drug Administration 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.
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.
Today in Healthy Living, a look at some devices recently added to the list.