Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled `Humanitarian Use Device (HUD) Designations.'' 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 HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway.
This guidance document is intended
- To assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
- To Demonstrate 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;
- Delineating a medically plausible subset of persons with a given disease or condition.
Devices that receive HUD designation may be eligible for marketing approval under an HDE application. A device is eligible for HDE approval if, among other criteria, the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. (See section 520(m) of the FD&C Act; 21 CFR 814.104(b)(2)). Although a HUD designation is a prerequisite to submitting an HDE application, it is only one of many required elements of the application (21 CFR 814.104). Receipt of a HUD designation does not guarantee that the HDE marketing application will be approved.
PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR Doc No: 2011-31867.
Or you can send your comments before March 12, 2012 at email@example.com and REF: HUD designation guidance.
For more information on this guidance you can go to the following link: For more information on this guidance you can go to the following link:http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUseDevicesHUDS/UCM283504.pdf