This chapter examines the FDA’s role in regulating ART devices. The FDA’s statutorily defined purview to regulate devices includes [things] “used in” or “intended to affect…man or other animals.” This chapter considers the FDA’s jurisdiction over devices that affect or diagnose pre-embryos, embryos, or fetuses that are not generally considered people or animals under US law. It discusses the legal and ethical implications of the FDA’s claim over ART devices without changing or clarifying its regulatory charge to include such organisms and whether or not the FDA has overstepped its power by regulating these instruments as devices. It also reviews the FDA’s existing classification of devices involved in ART (Class II). In light of the catastrophic and painful consequences that can follow malfunction of these devices (such as cryobanks thawing or embryo swapping) and that anecdotal accounts suggest such malfunctions are happening more frequently, this chapter questions if ART devices should be reclassified or if an alternative regulatory mechanism could more effectively protect consumers in the ART industry.