FDA Regulation of Quack Devices: It's a Miracle!...or Is It?

Abstract

Medical devices that presented substantial deception or an unreasonable and substantial risk of illness or injury have existed since the inception of this country. Even our forefathers such as Ben Franklin were subjected to these "quack" devices. It was not until the country's bicentennial, however, that explicit statutory provisions were enacted to allow the Food and Drug Administration ("the FDA") to ban quack devices. Even though active legislative steps have now been taken to regulate these useless medical devices, the problem continues to grow. This paper is an examination of the steps Congress and FDA have taken to regulate quack devices, where the organizations went wrong, and what should be done in the future.