Navigating the FDA and understanding medical device preemption

Abstract

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. In recent months the FDA and the courts have provided an array of changes to the landscape of medical device regulation. The medical profession and consumer groups have become increasingly critical of the FDA's process for approval of medical devices including studies published in the Journal of the American Medical Association and the American Journal of Therapeutics. However, as critics increase concern over safety, the ability of device manufacturers and emerging technology companies to put new products onto the market has never been easier.