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) plays an essential part in ensuring the efficacy and safety of any medical device.
To date, the FDA has approved more than 1,700 different types of medical devices, including 50,000 individual products.
The FDA uses a risk-focused classification system and categorizes medical devices into three distinct classes –
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 Class 3 category.
The classification system also considers the level of invasiveness and impact for patients too.
Class 2 medical devices are those with a moderate to high level of potential risk.
These are subject to general controls and special controls. These regulations may include compliance requirements for clinical testing data, performance, post-market surveillance, and labeling.
What are some Class 2 Medical Devices?
Some commonly used Class 2 medical devices include:
- Pregnancy test kits
- Blood pressure cuffs
- Blood transfusion devices
- Contact lenses
- Powered wheelchairs
- Certain software used as diagnostic tools
There is no specific category of device that decides its classification. Class 2 medical devices usually have more interactions, longer durations of sustained contact, and have a significant impact on 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 501(k)
- De Novo
Premarket notification is a pathway to the market for Class 2 medical devices. It is also called 501(k) and includes product submission to the FDA. This submission should demonstrate the below:
- The proposed device is visibly similar to an existing and legally marketed US product, and
- It is safe and effective as the similar device
To know the complete premarket notification process, you can visit this link https://www.greenlight.guru/blog/.
De Novo Classification Request is the second pathway for the production of Class 2 medical devices. This request uses a risk-centric process, similar to 501(k).
The difference is that the De Novo process does not compare existing equivalence criteria of a similar approved device.
The reason behind this is that 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 which are classified under low to moderate risk levels.
What are the Exemptions for Class 2 Medical Devices?
The FDA has provided exemptions from 501(k) to certain devices. These medical devices do not need a reasonable assurance of efficacy and safety.
These devices are hence exempted from product submissions. However, such devices will need to follow all applicable regulatory requirements and controls, under CFR Part 820.
To find out the complete list of exempted Class 2 medical devices, you can click on this link https://www.accessdata.fda.gov/scripts/cdrh/.
The Class 2 medical devices are the second most commonly used products in the healthcare industry. Once you understand the classification system, it becomes easier to design and market your product in the most effective and impactful way possible.
Make sure to check the official FDA guidelines regarding medical device classification to ensure that your product submission and approval process is streamlined and smooth.
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