Classifying equipment used in medicine can be a complicated process. The U.S. Food and Drug Administration (FDA) has a specific system for classifying this equipment, and for the layman it may not always be easy to understand. When it comes to industries involved in medical device manufacturing, their products are classified by the FDA into one of three categories: Class I, Class II, or Class III. Here is what you need to know.

Class I Devices

Class I medical devices are considered the lowest risk devices and are subject to the least amount of regulatory control. Examples of Class I devices include bandages, stethoscopes, and tongue depressors. 

These devices are considered to have a low potential for harm and are therefore exempt from pre-market notification requirements. However, manufacturers of Class I devices must still register with the FDA and comply with general controls, such as labeling requirements.

Class II Devices

Class II medical devices are considered to have a moderate risk and are subject to more regulatory control than Class I devices. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. 

These devices are subject to pre-market notification requirements, meaning that manufacturers must submit a 510(k) pre-market notification to the FDA before they can market their device. The 510(k) must demonstrate that the device is substantially equivalent to a device that is already on the market. 

Manufacturers of Class II devices must also comply with general controls, as well as special controls, which may include performance standards, post-market surveillance, and patient registries.

Class III Devices

Class III medical devices are considered to have the highest risk and are subject to the most regulatory control. Examples of Class III devices include pacemakers, implantable defibrillators, and heart valves. 

These devices are subject to pre-market approval (PMA) requirements, meaning that manufacturers must submit a PMA application to the FDA before they can market their device. The PMA must demonstrate that the device is safe and effective for its intended use. Manufacturers of Class III devices must also comply with general controls and any special controls that the FDA deems necessary.

Because medical device manufacturing takes care and experience, rely on a firm you can trust, such as Pacific Integrated Manufacturing in Bonita, CA. For over 20 years, this company has provided industry-leading products and is ready to become your long-term manufacturing partner. Call them at (619) 921-3464 to discuss what they can do for you, and visit their website for more information.