Class III Medical Device
A series of medical devices are available on the market, and are classified into different sub-categories like Class I, Class II, and Class III devices. As per “the Food and Drug Administration,” the medical devices are classified into these three categories. Out of which, you will get to know about Class 3 medical devices from here.
About Class 3 Medical Device
The most basic question that people ask is ‘What is class 3 medical device?’
Every design is categorized into three regulatory classes depending on the control level needed to ensure effectiveness and safety. These categories of medical devices have a higher risk to users and patients. They can be implanted, and can support or sustain life, etc. They represent around 10% of the medical devices, including pacemakers, defibrillators, implanted prosthetics, and breast implants.
Things That Make A Device ‘Class III’
There are certain factors that make a device Class III. Here are some of them:
- Devices whose risk-benefit profile is unfavorable or unknown
- Products that have known risks and cannot be controlled.
- Devices that have received a pre-marketing review regarding a change affecting effectiveness and safety.
- Products that need a full manufacturing review information.
- Combination products with a primary device model of action stating the drug constituent is effective and safe.
- A high-risk device is suitable for sustaining human life and holds substantial importance to preventing health impairment. It is also important to find out whether the device has a potential unreasonable risk of injury or illness.
A Short Description On Class I, II, And III
The classification of devices is confusing because of the limitation of exposure. There is a huge difference for manufacturers in the way devices are grouped. If you wish to know what are class I II and III medical devices, check this section.
- Class I medical devices: They are low to moderate risks to users and patients. Around 47% of devices come under this section, and 95% are eliminated from the regulatory process. There is no need for FDA clearance and a premature notification application before marketing it. Some examples of this category of devices are elastic bandages, enema kits, bedpans, and manual stethoscopes.
- Class II medical devices: These devices can pose moderate to high risk to users or patients. Under this category comes around 43% of devices. Most of them are counted to be Class II devices. Some examples are pregnancy test kits, powered wheelchairs, etc.
- Class III medical devices: These categories of devices have a risk to users or patients. They can support or sustain life and even present an unreasonable risk of injury or illness. Some class III devices examples are breast implants, implantable pacemakers, etc.
How To Differentiate The Three Categories?
In simple words, if you ask what determines which category of medical device you have? The simple answer to understand is the risk. The risk factor will also differentiate the medical devices into three categories. Every medical device is classified according to the risk associated with it. When the class is higher, the greater are the regulatory norms, it defines the requirements for the type of a general device. Classification is not only defined by the risk factor but also by the intended usage. With that, the usage of specialized indications is also considered.
Three Categories Of Class III Devices
In addition, the level of control for ensuring adequate safety and benefits are also taken into consideration. Class III devices are those types important to patients’ health but are of high-risks. With these devices, special and general controls are insufficient to establish efficacy and safety. They fall under three categories:
- Used for sustaining or supporting human life
- Presenting an unreasonable risk of injury
- Sustainable importance to prevent human health impairment
- The class 3 medical devices follow rigorous controls and need a De Novo. or a Premarket Approval (PMA) submission.
Examples Of Class III Devices
Several class III devices are present on the market, which can fulfill various desires. Some class III devices examples are renal stents, cochlear implants, wearable automated external defibrillators, implantable pacemaker pulse-generators, and high-frequency ventilators. In categorizing a class III medical device, the manufacturers need to undergo the associated costs and highest level of FDA scrutiny. Only 10% of devices receive a Class III designation out of all.
The Most Cutting-Edge And Innovative Medical Devices
Class III is reserved for the most innovative and cutting-edge medical devices for several reasons. Some devices of class II can be bumped into class III when a manufacturer cannot provide substantial equivalence under the PMA (510K) filing process.
Getting Class III Medical Devices In The Market
According to the PMA, class III is the most intensive type of device needed by the FDA. Some devices are exempted and must qualify for a 510(K) filing, but many of them need Premarket approval. It is a study on the device to provide details of effectiveness and safety through the risk profile and a data-driven benefit. It involves a huge amount of resources and time with clinical trials to collect sufficient data. During this time, it performs a substantive review of the quality system.
How To Find Out If FDA Approves A Device?
In order to find out if FDA approves a device, you need to check the FDA 510(K) Premarket Notification Database. All this information will indicate if a particular device falls under class II or not. If you do not get this detail, look for the FDA Premarket Approval (PMA) database. You can also determine the lifecycle and designing control of the devices.
The Bottom Line
Here are all resources and information to find out the classification of medication devices. These details will help in finding whether a particular device will meet a specific set of compliances or not. Attaining all compliances is an ultimate parameter of quality. It determines the fate of the company and device. Hopefully, this information will be helpful to you in understanding what class 3 devices are and how they are categorized.
If you need some help to deal with the FDA registration for your medical device you can contact us for a preliminary discussion. We also provide service for 510k submission.