Clinical Trials and Medtech

The question is often asked: “Why don’t all new medical devices require clinical trials the same way for a new drug?” The simple answer is that they are not needed to determine the safety and effectiveness for the vast majority of devices.

Clinical trials are required for high-risk devices and those that are “really novel,” Dr. Susan Alpert explains, “where we don’t understand the safety or the benefits.”

But, as Alpert cautions, “No clinical trial should be done unless there’s something specific that needs to be known. You don’t enroll patients into research unless there’s a question that must be answered by clinical trial.”

She explains that manufacturers and regulators can evaluate a new medical technology based on design, materials, bench testing and animal testing. This data can provide much of the basis for a safety and effectiveness determination. In many cases, clinical trials are simple needed “to confirm what we already know.”

As a result, clinical trials for devices can be much smaller than is typically the case for a new drug “and still be significant to answer the question,” Alpert adds.

Get more information from Dr. Alpert about the use of clinical trials and medical technology in the video below. Learn more about Premarket Requirements.

Never miss a post! Subscribe to our newsletter today!

Subscribe Now