FDA has recently issued a draft guidance titled, "Humanitarian Device Exemption (HDE): Questions and Answers."
It is now available on FDA's website at the following web link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf
This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and the Humanitarian Device Exemption (HDE) authorized under section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 613 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), signed into law on July 9, 2012, amended section 520(m) of the FD&C Act. This guidance document also reflects changes in the HDE program resulting from FDASIA.
Comments are due by May 19, 2014.