FDA Offers Guidance on Humanitarian Use Device Requests

The U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations. The guidance could help manufacturers apply to the Office of Orphan Products Development for HUD designations. After devices are designated as HUD, they still must earn humanitarian device exemptions from the Center for Devices and Radiological Health or Center for Biologics Evaluation and Research before gaining marketing approval. The 11-page guidance responds to a 2009 congressional requirement that the FDA establish a review group to make recommendations about treatment of rare diseases.
International Medical Device Regulatory Monitor