What is a HUD?
A Humanitarian Use Device (HUD) is a designation given to devices that may benefit patients being treated for a disease that affects less than 4,000 individuals in the U.S. per year. Because device manufacturers may be less inclined to put research and development costs towards devices for diseases in so few individuals, HUD provisions were created to provide greater access for the use of such devices. A sponsor or an investigator can apply for a humanitarian device exemption which authorizess marketing of the HUD. Additional information is available on the FDA website: http://www.fda.gov/cdrh/ode/guidance/1381.html.
A Humanitarian Use Device (HUD) is a designation given to devices that may benefit patients being treated for a disease that affects less than 4,000 individuals in the U.S. per year. Because device manufacturers may be less inclined to put research and development costs towards devices for diseases in so few individuals, HUD provisions were created to provide greater access for the use of such devices. A sponsor or an investigator can apply for a humanitarian device exemption which authorizes marketing of the HUD. Additional information is available on the FDA web site: http://www.fda.gov/cdrh/ode/guidance/1381.html.
