FDA regulations do not require review and approval for custom device use. However, FDA recommends that as many of the patient protection measures listed in paragraph 16 be followed as possible.
A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.