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

Area of Science:

• Medical Device Regulation
• Public Health Policy
• Consumer Protection Law

Background:

• The Food and Drug Administration (FDA) has historically limited consumer access to home-testing applications, including pregnancy, HIV, and direct-to-consumer (DTC) genetic tests.
• This restriction is based on the FDA's interpretation of

Purpose of the Study:

• To challenge the FDA's expansive interpretation of "safety" in regulating home-testing devices.
• To argue against judicial deference to the FDA's safety assessments for purely informative medical devices.

Main Methods:

• Historical analysis of FDA regulations and court deference doctrines.
• Examination of FDA's rationale for restricting access to home-testing technologies (pregnancy, HIV, DTC genetic tests).
• Legal argument against granting the FDA "super deference" on safety interpretations.

Main Results:

• The FDA has consistently restricted home-testing access, citing potential adverse consumer reactions to test results.
• Courts have historically granted significant deference to FDA's interpretations of "safety" and "effectiveness" due to the complexity of scientific matters.
• The FDA's safety concerns regarding home-testing devices have not always been based on rigorous scientific expertise regarding consumer responses.

Conclusions:

• Courts should not defer to the FDA's broad interpretation of "safety" when it restricts access to home-testing devices.
• The FDA should not possess the authority to make paternalistic value judgments about consumers' access to their personal health information.
• Re-evaluating FDA's regulatory approach to home-testing is crucial for consumer autonomy and access to information.