Posted by Michael Wonder on 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated information about the HDE application process and other considerations specific to the HDE Program.
An HDE application is the premarket submission for a Humanitarian Use Device, which is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in, not more than 8,000 individuals in the United States per year.
A device approved under an HDE application is exempt from the requirement to demonstrate a reasonable assurance of effectiveness.
