This guidance document is intended to assist sponsors, clinical investigators, and reviewers within the FDA on the review and analysis of Humanitarian Use Device (HUD) Designation applications that are submitted to the Office of Orphan Products Development. The guidance document shall provide clarification to FDA's expectations related to the content and identification of the number of patients who may benefit from a HUD as specified under 21 CFR § 814.102. In particular, the guidance document will provide clarification related to HUDs designated for diseases or conditions, medically plausible subsets, pediatric populations, and establishment of information when authoritative references do not exist. The guidance document will also include information on preparing the HUD application, clarification of common questions, and provide the address for submitting the HUD application.The draft guidance document entitled "Humanitarian Use Device (HUD) Designations" was published in the Federal Register on December 13, 2011. When completed, this document will assist applicants in the preparation and submission of HUD designation requests submitted to the Office of Orphan Products Development and FDA reviewers in evaluating such requests. The draft guidance document clarifies the content FDA expects device sponsors to provide and the criteria they must meet for identifying the number of patients who may benefit from a HUD, as specified under 21 CFR § 814.102. The draft guidance document also clarifies terms such as diseases or conditions, medically plausible subsets, pediatric populations, and explains how to provide needed information when authoritative references do not exist. Currently, the draft guidance document is out for public comment and the comment period will close March 12, 2012. This draft guidance also fulfills a requirement under the section 740c of the FY 2010 Appropriation Act (PL 111-80, October 21, 2009). The draft guidance, when finalized, will represent the Agency's current thinking on humanitarian use device (HUD) designations. COMPLETEDCOMPLETEDA. Set up core working group and identify HUD Guidance document writing assignments1/31/2011Completed1/19/2011B. Initial draft of HUD Guidance document3/31/2011Completed3/14/2011C. Hold meeting to update management on HUD Guidance document progress4/15/2011Completed4/5/2011D. Provide revised draft HUD Guidance document to Centers for review5/16/2011Completed4/5/2011E. Review and incorporate relevant comments from Centers into HUD Guidance document5/30/2011Completed5/10/2011F. Send revised draft HUD Guidance document to Centers with clearance due date of June 156/6/2011Completed5/27/2011G. Send draft HUD Guidance document to OCC for review and clearance6/29/2011<i>(10/31/2011)</i>Completed11/21/2011H. Send draft HUD Guidance document to the Office of Policy for review and final clearance by August 31, 20117/20/2011<i>(11/15/2011)</i>Completed12/5/2011word textword definitionhttp://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htmFDA-TRACK Office of Special Medical Programs Dashboard