Determining the class of a product is an important step in medical device manufacturing. The FDA uses these classifications to determine the type of clearance needed before bringing a new product to consumers. Here’s a guide to these classes and what they mean for companies that produce medical devices. 

What Are the Different Classes?

The FDA separates medical devices into Class I, II, and III. Class I devices are used in a general, non-invasive way. This category includes bandages, tongue depressors, and nonelectric wheelchairs. 

Class II is the most common category and includes devices deemed moderate risk. They are still non-invasive but may have potential consequences if they don’t work properly. This category includes blood pressure cuffs, powered wheelchairs, and most pregnancy tests. 

Class III includes high-risk devices and invasive devices. Many of them are used in surgical or life-saving procedures, like atrial defibrillators, fetal blood sampling monitors, and breast implants. 

How Do You Determine the Class for a Medical Device?

The easiest way to determine what category a new device may fall into is to compare it to similar options on the market. For example, if you’re producing a high-frequency ventilator, a search on the FDA’s database will reveal that these devices fall under Class III. Though this won't give you a binding answer—some devices can vary based on specific features, like the type of technology they use—it can give you a general idea.  

For a more official answer, submit a 513(g) request to the FDA. This form includes information about the intended use and any labeling claims you intend to make. The agency will then respond by mail with more information about your device. 

If you’re exploring the medical device manufacturing process, Pacific Integrated Manufacturing in Bonita, CA, is here to help. The company offers plastic injection molding customized to the needs of each client, and they take a “quality first” approach to ensure devices are up to industry standards. Visit their website for a full list of services, or call (619) 921-3464 to get a free quote on medical device manufacturing.