PMID: 29469551Feb 23, 2018Paper

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

Duke Law Journal
Shelby Baird

Abstract

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 judi...Continue Reading

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