From catheters to oxygen masks and ventilators, there are a wide range of medical devices used by hospitals and individuals. These pieces of equipment are required to meet certain safety and effectiveness guidelines set by the U.S. Food and Drug Administration (FDA). The approximately 1,700 types of devices produced by medical device manufacturing companies are grouped into three classes. Here’s what you need to know about each one.

A Guide to Medical Device Classes

Class I

The devices in this category typically have minor contact with individuals and their organs. Some examples include bandages, tongue depressors, and oxygen masks. Because the FDA considers these items inessential for sustaining life and relatively harmless if used incorrectly, they require the least amount of regulatory compliance.

Class II

Class II devices carry elevated risks of injury or impairment and involve more significant contact with patients. The FDA has an additional set of controls for the medical devices, such as labeling requirements and performance data logs.

In addition, the FDA requires a Premarket Notification (PMN)—also known as a 510(k)—that states a company’s intention of marketing a medical device and documents proof of the product’s safety and effectiveness. Some examples of Class II devices include catheters, syringes, blood transfusion kits, and contact lenses.

Class III

If the item produced by a medical device manufacturing company is used to sustain life or could result in injury or illness if used improperly, it typically falls into Class III. This category must meet an extended series of safety guidelines and premarket testing.

For instance, the FDA’s premarket approval process involves clinical trials, the creation of a risk profile, and the compilation of result data. Many Class III devices are considered innovative and must undergo stringent testing. Some that are currently on the market include pacemakers, breast implants, implanted prosthetics, and defibrillators.

For nearly 20 years, Pacific Integrated Manufacturing in Bonita, CA, has produced top-quality medical devices designed to exceed usefulness, safety, and FDA requirements. At its 50,000-square foot facility, state-of-the-art machines managed by skilled technicians create items that are deployed to hospitals, urgent care centers, and other illness and injury treatment facilities. To learn more about what the medical device manufacturing company has to offer, call (619) 921-3464. Visit the website for the complete lineup of available services.