First, it’s important to understand what the FDA classifies as a medical device. According to them, a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, diagnose disease in man”. The next step is to find out which of the three classes your product resides: Class Ⅰ, Class Ⅱ, or Class Ⅲ. The reason behind understanding what class your product is, is due to the fact that there are specific controls for each classification that you must adhere to.
Class Ⅰ Devices: Class 1 medical devices are considered to have a low to moderate risk to the patient and the user. These devices are subject to the least regulatory control and are often simpler in design and function compared to higher-risk medical devices. Some examples include exam gloves, dental floss, and bandages.Class Ⅱ Devices: Class 2 medical devices pose a moderate risk to patients and users. These devices are subject to more regulatory controls compared to Class I devices due to their higher level of risk. Examples of class 2 medical devices include pregnancy tests, surgical drapes, and thermometers.Class ⅠⅡ Devices: Class 3 medical devices are seen as the highest risk to patients and users. These devices are subject to the most stringent regulatory controls due to their significant potential for harm if they do not work as intended. Examples include defibrillators, artificial hearts, and implantable pacemakers.
To find your product’s classification, go to the FDA product classification database.
