What is an IDE?
An Investigational Device Exemption (IDE) is the mechanism by which new medical devices that could impose “significant risk” to patients/subjects are tested in the U.S. An IDE allows an investigational device to be utilized in a study in order to gather information on the safety and efficacy (effectiveness) of the device. An IDE is also required for an approved device which is being used off-label in a research study. Additional information is available on the FDA website:http://www.fda.gov/oc/ohrt/irbs/devices.htmlOrhttp://www.fda.gov/cdrh/devadvice/ide/index.shtml.
An Investigational Device Exemption (IDE) is the mechanism by which new medical devices that could impose “significant risk” to patients/subjects are tested in the U.S. An IDE allows an investigational device to be utilized in a study in order to gather information on the safety and efficacy (effectiveness) of the device. An IDE is also required for an approved device which is being used off-label in a research study. Additional information is available on the FDA website: http://www.fda.gov/oc/ohrt/irbs/devices.html Or http://www.fda.gov/cdrh/devadvice/ide/index.shtml.
An Investigational Device Exemption (IDE) is the mechanism by which new medical devices that could impose “significant risk” to patients/subjects are tested in the U.S. An IDE allows an investigational device to be utilized in a study in order to gather information on the safety and efficacy (effectiveness) of the device. An IDE is also required for an approved device which is being used off-label in a research study. Additional information is available on the FDA web site: http://www.fda.gov/oc/ohrt/irbs/devices.html Or http://www.fda.gov/cdrh/devadvice/ide/index.shtml. • 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.
