Litigating Medical Device Premarket Classification Decisions for Small Businesses: Have the Courts Given the FDA Too Much Deference? The Case for Taking the Focus Off of Efficacy

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the FDA’s high premarket review standards, several manufacturers have focused on international opportunities that allow them to place their devices into the market faster and at a lower cost. This Comment discusses the statutory history behind FDA premarket review authority arising under the Feed, Drug, and Cosmetics Act, the FDA’s progeny, and the FDA’s development of regulations designed to ensure that devices are deemed safe through product safety and efficacy determinations. In examining FDA regulations, this Comment reviews pertinent court decisions regarding device manufacturers’ challenges of FDA approval determinations based on safety and efficacy standards. This Comment then addresses how premarket regulations have impacted small businesses and outlines approaches the FDA could adopt to ameliorate systemic problems in the current approval process. Finally, this Comment argues that FDA premarket regulations should focus on product safety and shift product efficacy into the postmarket surveillance regulatory system, which could remove significant hurdles that show the device approval process without compromising patient safety