What is a medical device clinical trial?
A medical device is an instrument used to prevent or treat illnesses or other conditions. Examples of simple devices are tongue disposable gloves and medical thermometers. Diagnostic products are also considered medical devices like pregnancy test kits and imaging systems such as magnetic resonance imaging (MRI). When conducting implants, prostheses and medical testing, advanced devices like computers are used.
Medical device clinical investigations must comply with FDA’s human subject protection requirements, Institutional Review Board (IRB) requirements, Investigational Device Exemptions (IDE) requirements, Financial Disclosure for Clinical Investigators requirements regulations, as well as any other applicable regulations.
Like any other items/products that need to pass a certain requirement before it gets promoted and available for use, medical devices need to undergo clinical trials. Classification of medical devices is based on the risk that it poses to the patient and/or the user. This is how FDA (Federal Food, Drug, and Cosmetic Act) placed all medical devices into one of three regulatory classes. FDA needs to make sure that all medical devices will be classified by taking into consideration, the level of control necessary to ensure safety and effectiveness.
- Class I devices present the lowest potential for harm. These devices are subject only to general controls.
- Class II devices are those devices for which general controls alone are not sufficient to provide a reasonable assurance of effectiveness and safety. Examples of Class II devices are surgical drapes, infusion pumps and powered wheelchairs.
- Class III devices are devices like replacement heart valves, implanted cerebellar stimulators and silicone gel-filled breast implants. Generally, these are devices for which the information that exists is insufficient to identify that general or special controls are enough to generate a rational assurance of safety and effectiveness.
Before a manufacturer proposes to market a medical device, there should be a premarket notification, also referred to as 510(k). If FDA requires clinical data which they do in most 510(k)s, a study must comply with the IDE, IRB, and human subject protection. In most 510(k)s though, FDA does not require clinical data so the manufacturer may market the device immediately.
A premarket approval (PMA) application is the most rigorous and demanding type of device marketing application for medical devices where the FDA approves a PMA once and only if it establishes that the application contains adequate, valid & scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use.