The regulation of medical computer software as a 'device' under the Food, Drug, and Cosmetic Act.

Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a 'device' under the Food, Drug and Cosmetic Act (FDCA). The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.