What are Class 3 Medical Devices?

Class 3 Medical Device – Overview

The US Food and Drug Administration (FDA) is responsible for clearing, approving, or granting authorization for new medical devices before they are 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 significantly impact a patient’s overall health.

Class 3 medical devices are subject to strict regulatory controls and post-market surveillance to ensure safety and effectiveness, not necessarily permanent monitoring by the manufacturer.

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. The Class 3 category is usually 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 determining the class for your medical device using a risk-centric system to assess it.

What are Examples of Class 3 Medical Devices

Some of the most commonly used Class 3 medical devices include:

These and similar 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, 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.

The pre-market approval process is the most intensive marketing application the FDA requires for medical devices. Certain medical devices may qualify for a 510(k) clearance, not a ‘501(k)’ application if they can demonstrate substantial equivalence to a legally marketed device.

All Class 3 medical devices not qualifying for the 510(k) clearance process require Pre-Market Approval (PMA) by the FDA before being marketed.

The PMA process requires an in-depth study of medical devices’ safety and efficacy. This is done using a data-driven benefit vs. risk profile.

This process usually requires clinical trials. Along with this, significant resources are needed to ensure optimal data collection. The FDA then performs a substantive review of your quality system.

A 510(k) clearance is an alternative process for devices that can demonstrate substantial equivalence to an already legally marketed device, not an exemption but an alternate pathway for certain Class 3 devices.

To determine the classification of a medical device, manufacturers should consult the FDA’s official database or contact the FDA directly for guidance, as the provided link is a general entry point to the FDA’s database, not a direct link to classification information.


Even after your product receives the class 3 category, you must constantly monitor its quality.

This is an excellent way to prepare for the post-marketing review, which the FDA frequently performs to ensure the top quality and safety of medical devices being sold in the market.

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Current Version
March 19, 2022
Written By
Shubham Grover
March 25, 2024
Updated By
Daniyal Haider, MD

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