Navigating the Federal Regulatory Structure of Assisted Reproduction Technology Clinics

This article analyzes the current federal regulatory framework specific to clinics in the United States that use assisted reproductive technologies (ART). ART refers to “all treatments or procedures which include the handling of human oocytes or embryos, including in vitro fertilization . . . .”¹ The Centers for Disease Control and Prevention (CDC) found for the period of 2011 to 2015 that 12 percent of women — married and unmarried — reported problems conceiving or carrying a baby to term.² Similarly, about 15 percent of couples in the United States have some degree of infertility.³ In 2014, 1.6 percent of all babies born in the United States were conceived through ART,⁴ up from 1.0 percent in 2006.⁵