HDE

The device first needs a HUD designation, and the HDE then shows safety and probable benefit instead of effectiveness. Use at a facility generally requires IRB approval.

HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the act as authorized by section 520(m)(2) of the act. (n) HUD (humanitarian use device) means 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.

21 CFR, 814.3