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Author: Carrie Britton | Date: April 8, 2021
One of the most common questions when it comes to medical device regulation is, “What is the difference between a Class I and Class II medical device?” Today, we will explore the topic in more detail.
Medical devices in the U.S. are regulated based on an FDA classification system that evaluates the level of benefit and risk posed by the product and the level of control needed to ensure adequate safety. While the device classification system has been modified by subsequent amendments, it generally remains as originally intended.
Classification is generally established based on its intended use (its general purpose or function) and indications for use (the disease or condition it is designed to diagnose, treat, prevent, cure or mitigate). The FDA has established classifications for approximately 1,700 different generic types of devices which are grouped into 16 medical specialties.
The three classes are:
As we delve into the difference between a Class I and Class II medical device, we will answer some commonly asked questions.
Class I medical devices are subject to the FDA’s general controls and “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class I devices have a low impact on patients’ overall health and do not come into contact with their organs, the central nervous system or the cardiovascular system. These devices are subject to the fewest regulatory requirements.
General controls include:
Approximately 47% of medical devices are considered a Class I medical device, 95% of which are exempt from the regulatory process. Examples of Class I medical devices include elastic bandages, examination gloves, electric toothbrushes, hospital beds and hand-held surgical instruments, to name a few.
While there are many foundational differences between a Class I and Class II medical device, both may be eligible for a 510(k) exemption. These devices may be sold in the U.S. once the manufacturer registers and lists them with the FDA and complies with the applicable requirements in Title 21 of the CFR. Some exempt devices are also exempt from the Quality System Regulation (GMP), with the exception of Records (§820.180) and Complaints (§820.198).
Examples of 510(k)-exempt devices include stethoscopes, nonprescriptive sunglasses, dental burs and removable skin staples.
The main difference between a Class I and Class II medical device is its risk level. Class II devices are intermediate-risk devices for which general controls are not sufficient to ensure safety and effectiveness. These devices must meet general controls as well as special controls, if applicable, which include:
A Class II medical device, simply put, is a device that poses a greater risk to patients than a Class I. One of the most notable differences between a Class I and Class II medical device is the issue of premarket notification. Most Class II devices require a 510(k), demonstrating that their device is Substantially Equivalent (SE) to one or more predicate devices previously cleared by the FDA. Examples include endosseous implants, OTC blood glucose monitoring systems and scalp cooling systems.
For many Class II devices, the FDA has identified product code-specific guidance documents and Recognized Consensus Standards as part of their special controls. These types of FDA guidance and standards are also referred to as “vertical” because they pertain to a specific type of device, such as a dental implant, as opposed to a general device characteristic, like sterilization, according to the FDA’s Recognized Consensus Standards.
Additionally, there may be other relevant FDA guidance and standards not specifically referenced for a product code that is of a more generic nature. These types of FDA guidance and standards are referred to as “horizontal,” as they pertain to a wide range of medical devices within different device branches of the CDRH. Guidance documents and standards may also apply to a device exempt from 510(k), unless the device is also exempt from the QSR or GMPs.
Another primary difference between a Class I and a Class II device is a Class II device is more likely to come into sustained contact with the patient. This might include wheelchairs, infusion pumps, syringes, pregnancy test kits and surgical drapes, to name a few.
What is the difference between a Class I and Class II medical device? In essence, it comes down to the level of risk and the degree to which the device comes into contact with the patient. Class I devices present minimal harm to the patient and are generally simple in design. Class II devices, while typically non-invasive, pose a higher degree of risk and must offer a higher level of assurance that it will not cause injury or harm.
At Sterling Medical Devices, our medical device regulatory compliance consultants can help you decipher the difference between a Class I and Class II medical device, so you can meet the required regulatory controls that assure your medical device’s safety and effectiveness—throughout the entire product development life cycle.
Stay tuned. Next month, we’ll delve into Class III devices—the most complex and cutting-edge of the medical devices on the market.
February 18, 2021