FDA Guidance: How to Win Humanitarian Use Device Designation

The US Food and Drug Administration (FDA) released new draft guidance detailing the submission process for products seeking humanitarian use device designation for the US market. The document aims to define expectations for med-tech manufacturers as well as FDA reviewers considering Humanitarian-Use Device (HUD) applications. HUD designation is the first step to market clearance under a humanitarian device exemption.  The humanitarian use device program, run by the agency's Office of Orphan Products Development, applies to devices that diagnose or treat diseases and conditions affecting fewer than 4,000 people in the US per year. The draft guidance details how a manufacturer might define a patient population, demonstrate that the device works for that population and how the demonstration varies depending on whether the device is meant for diagnosis or treatment. The watchdog agency is accepting comments on the proposed guidance until 12 March, 2012. (MassDevice)