Substantially Unequivalent

Reforming FDA Regulation of Medical Devices

Amidst today’s era of ever-growing advances in technology lies an ever-increasing wealth of knowledge and information regarding the human body and the innumerable health issues and risks people encounter on a daily basis. Naturally, such advances in technology have led to groundbreaking medical techniques and treatments. Indeed,today’s market is host to a myriad of evolving drugs and medical devices that allow patients the ability to put up stronger fights as they battle for improved health conditions and enhanced qualities of life. With one’s quality of life at stake, it follows that innovations in the treatment of medical issues do not simply gain blind public acceptance and implementation without first encountering strict scientific and technical scrutiny. Or, at least, so one would think. Certainly,as required by the FDA, drug manufacturers in the United States must subject their products to the most stringent of regulations and methodical testing and re-testing before receiving market approval. Nevertheless, while such cautious and meticulous safeguards existamong the regulation of drugs, regulation of medical devices has yetto receive the same careful consideration and inspection.In fact, the FDA approval process for medical devices has beena topic of growing controversy. Over the past several years, reports have surfaced of patients being seriously injured—and even killed—by common medical devices, such as the seemingly harmless artificial hip implant. Currently, the 510(k) premarket approval process remains the means by which most new medical devices (approximately ninety-five percent), including high-risk devices, are cleared for the market. At the core of the 510(k) process exists the concept of “substantial equivalence,” whereby a device shown to be substantially similar to one already on the market will be approved without any clinical trials proving safety or efficacy. Although the United States has begun taking a few steps in the right direction to protect its people from the risks associated with medical devices, the time has come for lawmakers to instigate a real change in the medical device regulatory system. This Note beginswith an overview and comparison of the statutory history and regulatory systems for drug and medical devices in the United States. Next,this Note analyzes two different approaches to the 510(k) process that currently controls market acceptance for the majority of new medical devices. Finally, this Note demonstrates that a middle-ground approach that alters portions of the premarket and postmarket regulatory framework would be a beneficial way to begin the reformation process. Specifically, this Note emphasizes the importance of striking a balance between innovation, safety, and effectiveness when regulating medical devices.

The full text of this Note is available to download as a PDF.