There are various processes that FDA use to review information about medical devices before they are allowed to be marketed in the United States:

  • Premarket Notification [510(k)] – submission required to demonstrate that the device is substantially equivalent to a device already placed into one of the three device classifications before it is marketed.
  • Premarket Approval (PMA) – application required to demonstrate that the device is safe and effective when used. It is the most stringent type of device marketing application and is required for Class III devices.
  • Humanitarian Device Exemption (HDE) – a marketing application for a Humanitarian Use Device (HUD). An HUD is a medical device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in not more than 8,000 individuals in the United States per year.