Healthy Living: Fast Track To FDA Approval - Northern Michigan's News Leader

Healthy Living: Fast Track To FDA Approval

Posted: Updated:

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.