How Do Medical Device Clinical Trials Work?

Like medications, medical devices must go through a testing process before they can be approved for patients. Medical device clinical trials function in a different way so simple devices can reach patients faster. The approval process also ensures more complex devices are thoroughly tested.

What is a medical device?

When you think of medical devices, complex instruments like a prosthetic hip replacement or surgical robot may come to mind. But small items such as bandages and tongue depressors are also considered to be medical devices. The FDA defines a medical device as anything that treats a patient without medication.

What are medical device classes?

Because the definition of "medical device" is so broad in the eyes of the FDA, the agency divides devices into different classes. A device's class determines what kind of testing it needs to go through for approval.

Class I devices are products like latex gloves, bandages, and other everyday items. They're generally exempt from testing. For context, 47% of medical devices fall under this category, and 95% are exempt from regulatory testing. Examples of exempt devices include bedpans, mercury thermometers, and manual stethoscopes.

Some Class I devices require 510(k) premarket notification, letting the FDA know that the device will be released into the market 90 days in advance. This gives the FDA the chance to determine whether the device is equivalent to one that's already in the market.

Class II devices do require regulation, and include some pregnancy test kits and powered wheelchairs. These are devices that pose a higher risk to patients, so it's important that they're formally tested before being approved. Knee prosthesis and single-use scalpels also fall under this category.

Class III devices carry the highest risk for patients. They usually sustain or support life or are implanted in the body. An insulin pen or a stent are two examples of Class III devices.

How are new medical devices approved?

Class II and Class III devices go through a system similar to the drug clinical trial process, with a few differences.

Drug clinical trials start with a Phase I trial that's generally conducted with healthy volunteers. This phase only tests the drug for safety, not for effectiveness. For medical device trials, it typically doesn't make sense to enroll healthy volunteers. Medical device trials also typically can't use a placebo, for ethical or practical reasons.

Instead, the medical device approval process begins with a pilot study that enrolls 10 to 30 subjects. This stage determines preliminary safety and performance information. If researchers determine the device is safe and effective in this stage, the device moves on to a pivotal trial. This phase enrolls 150 to 300 volunteers and measures safety and effectiveness in a larger group of patients. After that phase, the manufacturer may submit the device for FDA approval.

Like drug trials, the device manufacturer may choose to conduct post-marketing trials. These trials continue monitoring how the device works for patients.

Whether you participate in a drug trial or device trial, research needs volunteers to bring new treatment options to patients. If you're interested in taking part, start your search for a trial near you below.