The Difference Between Class 1, 2, and 3 Medical Devices
Medical devices are essential to healthcare, and their regulation is crucial to ensuring patient safety. They range from simple bandages and thermometers to complex diagnostic and therapeutic tools like MRIs and pacemakers. In the United States, medical devices are categorized into three classes based on their potential risks to patients.
This article will provide an overview of medical device classes and explain the difference between Class 1, 2, and 3 medical devices.
Class 1 medical devices are often called “general control” devices because they are subject to the lowest level of regulatory oversight. These devices are considered low-risk and have a low potential for harm to the patient. However, manufacturers of Class 1 devices are still required to follow certain regulations to ensure their products’ safety and effectiveness.
Some examples of Class 1 medical devices are:
- Tongue depressors
- Disposable gloves
- Dental floss
- Blood pressure cuffs
- Non-invasive diagnostic devices (such as a pulse oximeter)
- Specimen containers
- Wheelchairs and crutches
- Syringes and needles for non-injectable use
- Contact lenses and eyeglasses
- Hearing aids
Class 2 products are subject to more regulatory controls. These devices have a moderate potential for harm to the patient and are often used for diagnostic and therapeutic purposes. Manufacturers of Class 2 devices must submit a 510(k) premarket notification to the FDA, including information on the safety and effectiveness of the device.
Some examples of Class 2 medical devices include:
- Powered wheelchairs and scooters
- Infusion pumps
- Surgical drapes and gowns
- Blood glucose meters
- Hemodialysis equipment
- Pregnancy tests
- Electrocardiogram machines
- Contact lenses and eyeglasses with prescription lenses
Class 3 medical devices are considered high-risk devices, with a potential for serious harm to the patient. They are often used for life-sustaining or life-supporting purposes or have a high possibility of misuse or malfunction. Therefore, manufacturers of Class 3 devices are required to submit a premarket approval (PMA) application to the FDA.
Examples of Class 3 medical devices include:
- Implantable pacemakers and defibrillators
- Artificial heart valves and heart-lung bypass machines
- Deep brain stimulation devices for Parkinson’s disease
- Infusion pumps for chemotherapy and pain management
- Spinal cord stimulators for chronic pain
- Prosthetic heart devices and ventricular assist devices
- Laser surgery devices for eye surgery
Speed Up Your Medical Device Development With Omnica Corporation
If you are looking for streamlined medical device development services for your Class 1, 2, or 3 devices, IVD systems, or laboratory instrumentation, Omnica Corporation can help! Our industrial design and medical engineering facility in Los Angeles has specialized resources that allow us to build almost any medical device. In addition, our team of experts can help trim significant time from most projects, so you can bring your product to market faster and more efficiently.
We understand the importance of precision and compliance in the medical industry. Therefore, we will work tirelessly to ensure your product meets all necessary standards and regulations.
Contact us today to learn more about our services and how we can help you optimize your medical device development process!
Who We Are
Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.
Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.