The Food and Drug Administration (FDA) is issuing a draft guidance document to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the FDA Office of Orphan Products Development (OOPD).  Topics addressed in this guidance include: 1)  demonstrating in HUD requests that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year;  2) how this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes; 3) how properties of the device may affect this demonstration; and 4) identifying a medically plausible subset of persons with a given disease or condition for the purpose of a HUD request.

 

The comment period regarding this draft document has closed.  Public submissions of comments to the draft HUD designation request guidance may be viewed at www.regulations.gov by searching the docket number, [FDA-2011-D-0847].

The FDA is currently reviewing comments that have been received.