Class “I” Devices
The FDA has established classifications for about 1,700 different types of devices. Each type of device is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
Class I devices are defined as “low to moderate risk”. These include simple, low-tech products like bandages and tongue depressors. Roughly half of all medical devices on the market in the United States fall into the Class I category.
Class I devices have little contact with patients and have minimal impact on a patient’s overall health. In general, Class I devices do not come into contact with a patient’s internal organs, the central nervous system, or cardiovascular system. These devices are subject to the fewest regulatory requirements. For example, most Personal Protective Equipment (PPE) falls under Class I; sterilizers and thermometers tend to fall under Class II; and ventilators and testing kits tend to fall under Class III.
In addition to being the simplest and least risky devices, Class I devices also have the fewest registration requirements. The type of classification a device receives dictates the type of submission the manufacturer will have to file with the FDA in order to allow it to be sold in the United States. Depending on the complexity of the device and the submission type, a response from the FDA can take as little as 90 days or more than a year.
Many Class I medical devices are exempted from submitting a 510(k)Premarket Notification and Premarket Approval (PMA). For this reason, Class I devices are the fastest and easiest to bring to market.
If a device is not exempt, a 510(k) pre-market notification will be required for marketing. If a 510(k) pre-market notification is all that is required, a device can get approved in as few as 90 days, though the process usually takes around 170 days.
Though most Class I devices are exempted from having to submit a 510(k) pre-market notification, devices in the other classes are not exempt. In addition, a Class I device that is exempt from 510(k) requirements must still comply with regulatory controls unless it is explicitly stated in the regulations that the device is exempt from those requirements.
Class I devices are also subject to General Controls. General controls apply to all medical devices unless the regulations state an exemption in the regulation for that device. For example, even a device as simple as a toothbrush is subject to general controls—though toothbrushes also have some exemptions. Other examples of Class I medical devices include, oxygen masks, reusable surgical scalpels, and hospital beds.
All medical devices are also subject to the Quality System Regulation, which is also known as the “Current Good Manufacturing Practices” or “Good Manufacturing Practices,” unless there is an exception or exemption noted.
It’s important to determine what type of classification will apply to a device to know which requirements must be met, which exemptions apply, and how long to expect the process to take.