FDA Classifications For Medical Devices
A medical device is any instrument used to diagnose, prevent, or treat a medical condition or disease without having any chemical action on any part of the body. Currently, there are 3 classes of medical devices including Class I, Class II, and Class III.
- Class I devices have low to moderate risk to the patient and or user. Currently, roughly 47% of all medical devices fall under this category with 95% of them exempt from the regulatory process. If a device falls into the exempted category of Class I devices, a premarket notification application, and FDA clearance are not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with the FDA. Examples of Class I devices include bandages, handheld surgical instruments, bedpans, manual stethoscopes, and nonelectric wheelchairs.
- Class II devices have moderate to high risk to the patient and the user. This category of devices makes up roughly 43% of all devices the FDA classifies. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications, powered wheelchairs, and even some pregnancy tests.
- Class III devices have high risk to the patient or the user and represent 10% of all medical devices that the FDA classifies. These devices are crucial to health or sustaining life like pacemakers and deep-brain stimulators, and even breast implants.
What Happens During The FDA Review Process?
Concept & Design: There must be a clinical need for a device in the healthcare market. The innovator, which can be a physician, engineer, and/or researcher, comes up with the idea for the device and works out the design and manufacturing of the device. During this phase, innovators often partner up with medical device companies who do a market analysis to determine which devices to support.
Animal Testing: There are instances where medical devices need to be tested on animals before they are studied in humans.
Clinical Trials: For devices that are Class III (not typically Class I or Class II), clinical trials that involve humans are required to determine if the device is safe for human use. Oftentimes these clinical trials are blind and randomized, but not always. High-risk devices that are non-approved are generally studied under an Investigational Device Exemption that requires strict oversight by the FDA’s Center for Devices and Radiological Health as well as a local institutional review board.
Device Review: Most Class I devices (and some Class II devices) are exempt from review if they are similar to existing devices or are extremely low risk. However, these devices still must comply with manufacturing and quality control standards.
Class II devices usually undergo a 510(k) review, which determines whether the new device is “substantially equivalent” to an existing device. 510(k) reviews usually do not require clinical trials to demonstrate whether or not they are “substantially equivalent”
Manufacturers of all Class III devices must submit a premarket approval (PMA) application where the FDA determines if the device is safe and effective at treating a medical condition. Along with the application, clinical trials for the device must be submitted.
What’s The Difference Between FDA Clearance And Approval?
Even after a medical device is classified, the FDA continues to monitor both the side effects and the performance of the device. This is done primarily when reports of malfunction are submitted. To further protect the public, the FDA mandates that manufacturers of certain devices meet post-market surveillance requirements.