Business · 24/01/2013

FDA Releases Guidance on Humanitarian Use Device (HUD) Designations

The Food and Drug Administration (FDA) has released a guidance document for industry and FDA staff on Humanitarian Use Device (HUD) Designations, outlining the criteria for devices to receive HUD designation and the process for submitting and evaluating HUD designation requests. The guidance finalizes a draft from December 2011 and aims to assist applicants and reviewers in the HUD designation process.