Medical devices are a staple of modern medicine and are responsible for many of the innovations in healthcare we see today. However, they aren’t all made equal and do carry their own degree of risk and harm. That’s why governing bodies introduced medical device classes I, II, and III (sometimes medical devices classes 1, 2, and 3) to help regulate them and assess their impact on patients, making way for proper manufacturing, safety, and usage protocols.
In this article, we’ll discuss the topic of medical device classification levels I and II, their characteristics, as well as how they differ from one another.
What Is A Medical Device? FDA Medical Device Definition
By definition, a medical device is an instrument, apparatus, machine, or implant intended for use in the diagnosis, mitigation, treatment, or prevention of disease. The term covers a broad range of healthcare products, and applies to any device that is used alone or in combination with another to prevent, diagnose, and treat illness.
As has already been mentioned, medical devices play a huge role in modern healthcare and are used in a variety of settings. This could be anything from a simple tongue depressor to something as complex as a heart pacemaker.
Given the wide range of uses and varying degrees of risk within the scope of medical devices, regulatory bodies such as the United States’ Food and Drug Administration (FDA) have created a medical device classification system.
The aim of this system is to provide a consistent regulatory framework that takes into account the risks associated with each device. This, in turn, will help to ensure patient safety during use. There are three primary classes of medical devices, with Class III products considered the highest risk and therefore requiring the most stringent regulation.
How Does The FDA Class a Medical Device?
The FDA has classifications for about 1,700 different types of generic medical devices and groups them into 16 specialties that they refer to as panels. They assign devices from these panels to one of three classes based on the degree of control necessary to use them both safely and effectively.
Knowing the class in which their product is categorized is important for medical device manufacturers because each level has its own application requirements and degree of regulatory control. Device exemptions and special controls will apply in some cases, but only to those that meet certain conditions and criteria.
What Is A Class I Medical Device?
The FDA class I medical device category applies to products considered to be low-risk and pose little to no harm to patients.
They make up 47% of medical devices today, 95% of which are exempt from the regulatory process. Products that fall into a generic category of exempted class I devices are not required to submit a premarket notification application or acquire FDA clearance prior to going to market in the United States. They are, however, required in all cases to register their establishment and list their product with the FDA.
FDA Class I Medical Device Requirements
Given the relatively benign nature of these products, manufacturers of class I medical devices are subject to the least amount of regulation. That being said, there are still general controls that must be adhered to in order to ensure patient safety.
Some of the regulatory requirements for class I medical devices include:
- Design and manufacturing controls
- Quality system regulation
- Labeling requirements
- Post-market surveillance
FDA Class I Medical Device Examples
As was already mentioned, class I medical devices make up a large portion of all medical devices in the US market. They are among some of the most commonly used tools in healthcare, and pose little to no risk to those administering or using them.
Examples of class I medical devices include:
- Most bandages
- Oxygen masks
- Latex gloves
- Manual stethoscopes
Credit: Mufid Majnun
What Is A Class II Medical Device?
Class II medical devices are those that may pose a moderate risk to patients and are therefore subject to more stringent regulation than class I products.
They make up around 43% of medical devices on the market today and must go through the FDA’s 510(k) premarket notification process in order to be cleared for commercial sale in the United States.
FDA Class II Medical Device Requirements
In order to be classified as a class II medical device, manufacturers must prove that their product is “substantially equivalent” to a device already on the market that has been given clearance by the FDA.
The premarket notification submission must include data that demonstrates this equivalence as well as a description of indications for use, proposed labeling, and any additional information that may be relevant to its safety and effectiveness.
The FDA determines what is a class II medical device and what isn’t. If it finds that a class II medical device 510(k) does not prove substantial equivalence to an existing product, it may deny the premarket notification and require that the product be reviewed or reclassified.
FDA Class II Medical Device Examples
While deemed to require a slightly higher degree of control than their class I counterparts, many class II medical devices are still among the most familiar healthcare products out there.
Examples of common FDA class II medical devices include:
- Blood pressure cuffs
- Pregnancy test kits
- Infusion pumps
- Blood transfusion kits
The Differences Between Medical Device class I and II – Which One Will My Product Be?
The main difference between the class I medical device and class II medical device categories is the level of risk they pose to patients. Class I devices are considered low-risk and Class II devices are considered to be moderate-risk. Class I devices make up the majority of medical devices on the market and are subject to less stringent regulation than class II medical devices.
Class II medical devices must go through the FDA’s 510(k) premarket notification process in order to be cleared for commercial sale. So, which one should your product be? The answer depends on the level of risk posed by your device. If your device is low-risk, then it will likely fall into Class I. If your device is moderate-risk, then it will likely fall into Class II.
Of course, this is not a hard and fast rule and there are always exceptions. Knowing which classification your device will fall under takes experience, like the 25+ years experience that RBC has in the medical device industry. If you are unsure which category your device falls into, talk to us.
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:
- Class I—general controls (with or without exemptions)
- Class II—general controls and special controls (with or without exemptions)
- Class III—general controls and premarket approval
As we delve into the difference between a Class I and Class II medical device, we will answer some commonly asked questions.
What’s the Difference Between a Class I and Class II Medical Device?
1. What is Considered a Class I Medical Device?
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:
- Device registration and listing
- Premarket notification (510(k)) (for a limited number of Class I devices)
- Notification and repair, replacement or refund
- Records and reports
- Banned devices
- Good manufacturing practices (unless exempt)
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.
2. What is a Class I Exempt Medical Device?
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.
3. What is a Class II Medical Device?
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:
- Performance standards
- Post-market surveillance
- Patient registries
- Guidances and guidelines
- And other appropriate actions
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.
Featured Photo Credit: HH E