What are the Different Medical Device Classes – Overview
The US FDA is responsible for regulating any medical device which is launched in the United States. These are broad groups into three distinct classes. These medical devices are normally classified according to the following:
- Potential risk
- Impact on patient’s health
Medical device manufacturers usually find this classification system complex, especially if they have had limited exposure. Depending on the classification of the device, the path from manufacturer to market is drastically different.
For instance, Class 1 medical devices have fewer regulatory requirements as compared to Class 2 or 3 devices.
It is important to know the class in which your proposed medical device would be categorized even before you start manufacturing it.
Different FDA Medical Device Classes
The FDA has categorized around 1,700 different types of medical devices. These are organized accordingly under the CFR (Code of Federal Regulations), in terms of 16 medical specialties.
The first step for manufacturers is to get their medical devices categorized.
The different specialties under which new medical devices are categorized include:
- ENT (Ear, Nose, Throat)
- General and Plastic Surgery
- Gastroenterology and Urology
- General Hospital
- Obstetrics and Gynecology
Once a designed device is approved and classified, the FDA gives the manufacturer the go-ahead to manufacture and market their device accordingly.
Class 1 Medical Devices
Class 1 medical devices are defined as those devices which are not meant for use in supporting or sustaining life.
These devices substantially prevent impairment to human health and may not provide an unreasonable risk of injury or illness.
Class 1 medical devices are the most common class in the market, as they constitute over 47% of the market share.
These devices have minimal contact with the patient while being used. These devices generally have a low impact on the patient’s health.
In short, class 1 medical devices are not attached to a patient’s internal organs, the cardiovascular system, or the central nervous system. These medical devices are subject to fewer FDA regulations.
Some examples of common Class 1 medical devices include:
- Hospital beds
- Tongue depressor
- Electric toothbrush
- Non-electric wheelchair
- Oxygen mask
Class 2 Medical Devices
Class 2 medical devices are comparatively more complicated and are more likely to come into substantial contact with the patient.
These devices are usually used to monitor or maintain a patient’s cardiovascular system or internal orgasm, such as various diagnostic tools.
The FDA defines Class 2 medical devices as those that do not require general controls to ensure their safety and effectiveness.
Some examples of Class 2 medical devices include:
- Blood pressure cuffs
- Pregnancy test kits
- Blood transfusion kits
- Contact lenses
- Absorbable sutures
- Surgical gloves
Class 3 Medical Devices
Class 3 medical devices are defined as those which usually support or sustain life and are present or implanted with a potential unreasonable risk of injury or illness.
Around 10% of the total medical devices in the market are categorized under Class 3 by the FDA. This class usually includes smart medical devices, permanent implants, and life support systems.
The class 3 category is usually reserved for the most innovative and high-tech medical devices. At times, some devices under Class 2 may be promoted to Class 3.
Some commonly used Class 3 medical devices include:
- Breast implants
- Cochlear implants
- High-frequency ventilators
- Implanted prosthetics
Identifying Medical Device Classes
The main differences between the 3 classes of medical devices have to do with the device’s impact, level of contact, and critical nature.
The FDA also considers substantial equivalence to determine the category of any new medical device. The FDA is concerned with the device’s safety and effectiveness before launching it on the market.
If your device is low-risk and requires minimal contact with the patient to work, it usually gets classified under Class 1.
This also means you have a more streamlined market approval process.
Knowing how your device is classified can help to determine the most efficient market approval process. You will know the type of documents you will require to be submitted to the FDA to get your device approved.
This classification knowledge will help you to allot relevant resources in advance and ensure a successful product launch.