Regulatory Update

| 01 August 2010

The long-awaited final guidance for Humanitarian Device Exemption holders, institutional review boards (IRBs), clinical investigators and US Food and Drug Administration staff was issued 8 July 2010 by CDRH/ODE and is now available to interested parties. The last updated draft guidance was issued 5 August 2008 and a previous regulation was issued 18 July 2006. This document supersedes all others. The guidance provides application and clinical submission information pertaining to Humanitarian Device Exemption for Humanitarian Use Devices (HUDs) authorized under section 510(m)(2) of the US Food, Drug and Cosmetic Act and sets forth additional requirements for pediatric device safety and improvement. The guidance provides clarification on when a HUD can be "used" vs. for "investigational use"/"clinical investigation."


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