Class 3 Medical Device – Overview
The US Food and Drug Administration (FDA) is assigned the task to approve and then classify any new medical device before it is marketed.
This process is mandatory for all new medical devices in the US. Every medical device manufacturer needs to get their new products approved and classified by the FDA.
This is essential if you wish to market the product to consumers.
Class 3 medical devices are usually those with a higher potential risk factor.
These are also usually those devices that are more invasive and have a more significant impact on a patient’s overall health.
These medical devices usually require permanent monitoring throughout their lifetime.
What is a Class 3 Medical Device?
Class 3 medical devices are those devices that pose a larger potential risk to patients/users.
These devices are usually life-sustaining or life-supporting products and are implanted or have a higher risk of causing potential injury or illness to the user/patient.
Currently, around 10% of medical devices sold in the market are categorized as Class 3 devices.
These are almost all permanent implants, life support systems, and smart medical devices. Usually, the Class 3 category is reserved for the most advanced and innovative medical devices.
However, the FDA also classifies other types of devices into Class 3 for various reasons.
At times, some Class 2 devices are also promoted to Class 3 if the manufacturer is unable to show significant equivalence with a similar existing FDA-approved product.
In such cases, the manufacturer can use the De Novo classification. This is an alternate path to determine the class for your medical device using a risk-centric system to assess your device.
What are Examples of Class 3 Medical Devices?
Some of the most commonly used Class 3 medical devices include:
- Breast implants
- Cochlear implants
- High-frequency ventilators
- Fetal blood sampling monitors
- Implanted prosthetics
These, and similar other products, are classified under Class 3 of medical devices by the US FDA.
How to get Class 3 Medical Devices from Manufacturing to Marketing?
Class 3 medical devices are subject to every FDA general control and PMA (pre-market approval) process. According to the FDA, the Class 3 medical devices pose the highest risk potential to users.
This compels the department to determine the general and special regulatory requirements to ensure optimal safety and efficiency of the medical device when used.
The pre-market approval process is the most intensive marketing application required by the FDA for medical devices. Certain Class 3 medical devices are exempt from this and may qualify for a 501(k) application.
However, the vast majority of Class 3 medical devices will need to go through PMA before launching the product in the market.
The PMA process requires in-depth study of medical devices, in terms of safety and efficacy. This is done using a data-driven benefit vs risk profile.
This process usually requires clinical trials. Along with this, it needs significant resources to ensure optimal data collection. The FDA then performs a substantive review of your quality system.
The single exemption to the PMA process for Class 3 medical devices is for those with a substantial equivalent product already in the market.
To determine the specific class of your proposed medical device, you can search the FDA database by clicking on this link https://www.accessdata.fda.gov.
Even after your product receives the class 3 category, you will need to monitor its quality constantly.
This is an excellent way to be prepared for the post-marketing review, which is frequently performed by the FDA to ensure the top quality and safety of medical devices being sold in the market.