Don’t Try This at Home: The FDA’s Restrictive Regulation of Home-Testing Devices


Over the past forty years, the Food and Drug Administration (FDA) has successfully restricted consumers’ access to home-testing applications based on the notion that it should protect individuals from their own reactions to test results. In the 1970s, the FDA briefly denied women access to home pregnancy tests that were identical to those used in laboratories. In the late 1980s and early 1990s, it relied on concerns about consumer responses to HIV status results to justify a categorical ban on applications for HIV home-testing technology. More recently, it placed burdensome restrictions on direct-to-consumer (DTC) genetic testing companies, such as 23andMe, based on fears that consumers would make irrational medical decisions after receiving genetic variant results.

Although the FDA has the statutory authority to ensure the “safety and effectiveness” of medical devices, it has expansively interpreted the term “safety” to encompass considerations of how consumers might use test results provided by purely informative devices. This Note argues that courts should not give the FDA deference on its broad interpretation of “safety” in restricting home-testing devices. It documents the evolution of the expertise-based rationale for judicial deference, noting that courts typically provide scientific agencies, including the FDA, “super deference” because of the complicated nature of their work. Ultimately, courts should not defer to the FDA’s interpretation of “safety” because it did not use its scientific expertise when it considered how consumers might react to HIV home-testing and DTC genetic testing results. Further, the FDA should not have the authority to make decisions based on its view of “safety” because it should not have the power to make value judgments for consumers about whether they should seek their personal medical information.