FDA Solicits Comments on Draft Guidance for Humanitarian Use Device Designations

December 13, 2011—In the Federal Register, the US Food and Drug Administration (FDA) announced a draft guidance for industry and FDA staff titled “Humanitarian Use Device (HUD) Designations.” The document is available on the FDA's Web site.

The FDA advised that this guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.

According to the FDA, devices are eligible for HUD designation if they are 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. Devices that receive a HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption marketing pathway.

Topics addressed in this guidance include: 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; how this demonstration varies, depending on whether the device is intended for therapeutic or diagnostic purposes; how properties of the device may affect this demonstration; and delineating a medically plausible subset of persons with a given disease or condition, stated the FDA.

To ensure that comments on this draft guidance are considered by the agency before it begins work on the final version of the guidance, the FDA recommended that electronic or written comments should be submitted by March 12, 2012. Electronic comments on the draft guidance should be submitted at http://www.regulations.gov. Written comments should be addressed to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.