In this blog, we will explain everything related to FDA Class II medical devices. Starting with the basics of FDA medical device classification, to a detailed explanation of Class II medical devices, and their clearance process.
Understanding FDA Medical Device Classification
In the United States, the Food and Drug Administration (FDA) categorizes medical devices into three classes based on perceived risk.
This classification is crucial because it dictates the data requirements and controls necessary to ensure the safety of patients and users. Not just this, but based on the classification, you can determine the regulatory path for your device.
The FDA evaluates each device’s classification based on three main factors:
⦿ Intended Use: What the device is designed to do?
⦿ Indications for Use: The specific conditions or patient populations for which the device is intended.
⦿ Risk Level: The potential risk posed to patients and users. You might also like to check out our article on intended use vs. indication use to understand the difference between the two terms.
Devices are classified as follows:
Class I:These devices present the lowest risk. They typically require minimal regulatory control and are subject to general controls.
For example, medical devices or products such as bandages, gauze, or surgical gloves fall under the class I medical devices.
Class II: These devices have a moderate risk and require more regulatory oversight, including special controls.
For example, infusion pumps, X-ray machines, or surgical lasers usually are categorized by FDA under Class II medical devices.
Class III: These devices pose the highest risk and require premarket approval involving rigorous testing and validation.
For example, devices like pacemakers, implantable defibrillators, or heart valves are categorized as high risk class II devices.
Understanding this classification system is vital for manufacturers, as it influences the regulatory pathway and necessary safety measures for their products.
To learn how to determine if your product falls under either of these categories, you must check out our guide, Determining whether your product is a medical device or not. In this blog, you will also find a section that elaborates on the medical device classification in the US.
Additionally, the FDA offers a Product Classification Database that aids in determining the appropriate classification for your device, including finding consensus standards and submission types, such as the 510(k) or PMA.
Understanding these classifications and regulatory requirements is essential for manufacturers to navigate the approval process effectively.In this blog we are going to discuss Class 2 medical devices, in particular, so let’s focus on those now.
What are Class II Medical Devices as per the FDA?
Class II medical devices pose a low to moderate risk to patients and users, and they represent about 43 percent of all medical devices in the United States.
These devices are subject to specific regulations to ensure their safety and effectiveness.
Common Examples of Class II Devices:
⦿ Syringes: Used for administering injections or drawing blood.
⦿ Pregnancy Test Kits: Home diagnostic tests for pregnancy detection.
⦿ Electric Wheelchairs: Mobility devices for individuals with limited mobility.
⦿ Catheters: Tubes used for various medical purposes, such as draining fluids.
Class 2 medical devices must comply with the provisions of the General Controls outlined in the Food, Drug, and Cosmetic (FD&C) Act, which applies to all device classes.
What are the pre-market submissions for Class II Medical Devices as per the US FDA?
Once you have determined that your medical device is a Class II medical device as per the FDA regulations, the next step you have to start thinking of is the approval or the clearance process. There are two potential pathways that you can follow to get your device approved by the US FDA in this case. These two pathways are –
⦿ Premarket Notification 510(k)
⦿ De Novo
Premarket Notification 510(k)
For most class II medical devices, the premarket notification is a must-have step for going to market. This is also commonly known as 510(k). This includes a process of providing the FDA with a sufficiently similar predicate device that is already being marketed in the US market. To learn more about the 510(k) submission, you can check out our guide, FDA 510(k) Submission: A Step-By-Step Guide.
A few more resources you might find helpful are:
⦿ US FDA’s 510(k) Submission & Review Process
⦿ Different types of 510k submissions | Special, Abbreviated vs Traditional 510(k)
⦿ 510(k) Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!
⦿ Predicate Device: What is it and How to Choose the Right One?
De Novo
Another option that you can go with for Class 2 medical devices is a De Novo Classification. This is a down classification request that is based on the risk associated with the device (similar to 510(k)) but with some different requirements. Where in 510(k) submission, substantial equivalence of the predicate device is a must, in De Novo, there is no need to use an existing device.
Why if you ask, well! The De Novo program was specifically designed for class II medical devices with no predicate device. This is the reason why De Novo’s request is best for the low to moderate risk medical devices that do not have a Predicate in the market. You can find out more about De Novo here in our blog, De Novo paving the path for Technological Advancements.
What Device Exemptions Exist for Class II Medical Devices?
There are several class 2 medical devices that, according to the FDA, do not need to undergo a 510(k) clearance or a De Novo submission. These devices are usually considered exempt medical devices. However, these devices, with some exceptions, still need to follow the applicable regulatory controls and requirements from 21 CFR Part 820.
You can find out if your medical device is exempt or not by checking our article Is your medical device 510(k) exempt? Understanding the classification of medical devices!
FDA has published a list of all class II medical devices that are currently exempt from product submissions here https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
We hope that this blog has helped you understand the basics of class 2 medical devices, their regulatory requirements, and more…
