What are Class 2 Medical Devices?

Class 2 Medical Device – Overview

Producing high-quality and reliable medical devices is the main goal of any manufacturer. This is incredibly important to improve or save a patient’s life.

The US FDA (Food and Drug Administration) is essential in ensuring the efficacy and safety of medical devices.

The FDA does not ‘approve’ all medical devices in the same manner as it approves drugs; instead, it ‘clears’ many devices for market entry, particularly Class 2 devices, through the 510(k) process.

The FDA uses a risk-focused classification system and categorizes medical devices into three distinct classes –

Class 1 Medical Devices

Class 2 Medical Devices

Class 3 Medical Devices

How does the FDA Categorize Class 2 Medical Devices

The FDA categorizes different types of medical devices under three distinct classes.

This classification system is risk-centric, with the lowest-risk devices assigned to Class 1 and higher-risk devices allotted to the Class 3 category.

The classification system also considers the level of invasiveness and impact on patients.

Class 2 medical devices are those with a moderate potential risk.

These are subject to general and unique controls. Special controls specific to Class 2 devices can include special labeling requirements, mandatory performance standards, and postmarket surveillance.

What are some Class 2 Medical Devices?

Some commonly used Class 2 medical devices include:

Pregnancy test kits
Blood pressure cuffs
Blood transfusion devices
Syringes
Contact lenses
Powered wheelchairs
Certain software used as diagnostic tools

No specific category of device decides its classification. Class 2 medical devices usually involve more interactions and longer durations of sustained contact and significantly impact the patient’s overall health.

If you want to check which category your proposed medical device falls into, you can simply check the official website at https://www.accessdata.fda.gov/scripts/cdrh/

What are the Pre-Market Submissions for Class 2 Medical Devices?

Once you have determined that your proposed medical device falls under the Class 2 category, you can evaluate one out of two processes to launch it:

Premarket Notification 510(k)
De Novo

Premarket Notification

Premarket notification is a pathway to the market for Class 2 medical devices. It is also known as 510(k) and includes product submission to the FDA. This submission should demonstrate the following:

The proposed device is visibly similar to an existing and legally marketed US product, and
It is as safe and effective as a similar device

Refer to the official FDA website for complete information on the premarket notification process.

De Novo

The De Novo classification request is the second pathway for producing Class 2 medical devices. This request uses a risk-centric process similar to 501(k).

The difference is that the De Novo process is used when there is no predicate device on which to base a comparison to demonstrate safety and effectiveness.

This is because the De Novo program is meant for Class 2 devices with no existing similar product for comparison. Due to this, the De Novo process is best for new medical devices classified under low to moderate risk levels.

What are the Exemptions for Class 2 Medical Devices

The FDA has provided certain medical device exemptions from 501(k). These devices do not need a reasonable assurance of efficacy and safety.

Hence, these devices are exempted from product submissions. However, such devices must still comply with applicable general controls and any other FDA requirements not specific to the 510(k) process.

To find the complete list of exempted Class 2 medical devices, click this link https://www.accessdata.fda.gov/scripts/cdrh/.

Conclusion

Class 2 medical devices are the second most commonly used products in the healthcare industry. Once you understand the classification system, designing and marketing your product in the most effective and impactful way possible becomes easier.

Check the official FDA guidelines regarding medical device classification to ensure that your product submission and approval process is smooth.

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