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U.S. Department of Health and Human Services

About FDA

Humanitarian Use Device (HUD) Guidance

Description: 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.

Accomplishment: The draft guidance document entitled "Humanitarian Use Device (HUD) Designations" was published in the Federal Register on December 13, 2011.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 The draft guidance document clarifies the content FDA expects device sponsors to provide and the criteria they must meet for identifying the number of patients who may benefit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 The draft guidance document also clarifies terms such as diseases or conditions, medically plausible subsets, pediatric populations, and explains how to provide needed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 Currently, the draft guidance document is out for public comment and the comment period will close March 12, 2012. This draft guidance also fulfills a requirement under the section 740c of the FY 2010 Appropriation Act (PL 111-80, October 21, 2009). The draft guidance, when finalized, will represent the Agency's current thinking on humanitarian use device (HUD) designations.

Briefing Status: COMPLETED

Prior Briefing Status: COMPLETED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Set up core working group and identify HUD Guidance document writing assignments

1/31/2011

Completed 1/19/2011

B. Initial draft of HUD Guidance document

3/31/2011

Completed 3/14/2011

C. Hold meeting to update management on HUD Guidance document progress

4/15/2011

Completed 4/5/2011

D. Provide revised draft HUD Guidance document to Centers for review

5/16/2011

Completed 4/5/2011

E. Review and incorporate relevant comments from Centers into HUD Guidance document

5/30/2011

Completed 5/10/2011

F. Send revised draft HUD Guidance document to Centers with clearance due date of June 15

6/6/2011

Completed 5/27/2011

G. Send draft HUD Guidance document to OCC for review and clearance

6/29/2011

(10/31/2011)

Completed 11/21/2011

H. Send draft HUD Guidance document to the Office of Policy for review and final clearance by August 31, 2011

7/20/2011

(11/15/2011)

Completed 12/5/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.