The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products

Abstract

This paper critiques the manner in which the Food and Drug Administration uses its discretionary authority to regulate the sale of home testing products. Part I provides the legal framework for FDA approval of home testing products and emphasizes the discretionary authority enjoyed by the agency. In particular, Part I details the responsibility of the FDA to ensure that marketed devices are both safe and effective. Part II details the manner in which the FDA has used its discretionary authority to prevent the sale of HIV blood collection kits. It supports the argument that the current system of regulation is marked by the FDA's excessive use of its statutory discretion.