Medical Devices; Humanitarian Use Devices

The Food and Drug Administration (FDA) is issuing a final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) regarding humanitarian use devices (HUD's). A HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. This final rule prescribes the procedures for submitting humanitarian device exemption (HDE) applications, amendments, and supplements; procedures for obtaining an extension of the exemption; and the criteria for FDA review and approval of HDE's. The purpose of this HDE is, to the extent consistent with the protection of the public health and safety and with ethical standards, to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States.