Dec 14, 2011

The US Food and Drug Administration has opened a 90-day comment period for draft guidance on Humanitarian Use Device (HUD) designations.

The HUD designation program, run by the Office of Orphan Products Development (OOPD), enables qualifying medical devices to be considered for marketing approval via a Humanitarian Device Exemption (HDE) application. HDE applications are similar to premarket approval applications, but do not require manufacturers to demonstrate reasonable assurances of effectiveness.

The draft guidance covers the following HUD-related issues:

  • Demonstrating that the device seeking HUD designation targets diseases affecting less than 4,000 people annually in the US
  • Variations of that demonstration depending on whether the device is designed for therapeutic or diagnostic use
  • How device properties affect that demonstration
  • Definition of a plausible patient population for the disease in question

Interested parties have 90 days to submit comments on the FDA’s proposals.


  • Stewart Eisenhart