The world of medical device standards and regulations is a complicated one. Regardless of where on the globe your company is located, you’ll be faced with several sets of laws that you must adhere to when getting approval on your medical device. However, the processes you must follow depend entirely on how your medical device is classified.
In the United States, the responsibility of regulating medical devices falls to the Center for Devices and Radiological Health (CDRH), a branch of the Food and Drug Administration (FDA). The CDRH’s main goal is to keep patients and healthcare providers safe, and so their classification process takes into account factors like the device’s intended use, if it’s surgically invasive or not, and the risk posed by device misuse or failure.
The Difference Between Class I, Class II and Class I Medical Devices
There are three main classes of medical devices: Class I, Class II and Class III.
Class I denotes that the device is low risk and therefore only require the least amount of regulatory control. Even if used improperly, Class I devices pose very little risk to both patients and providers, so they only have to meet the FDA's general controls for safety and quality. Examples of a Class I medical device are bandages, dental floss, tongue depressors, stethoscopes and other simple instruments.
Class II devices carry greater risk than Class I devices, making them subject to extra controls and precaution. This ensures that they meet the highest levels of safety, quality and effectiveness. Most medical devices on the market fall under Class II. Examples include x-ray machines, EKG machines, surgical needles, powered wheelchairs and other noninvasive instruments.
The third class is reserved for devices that are not only highly complex and invasive, but are also used to sustain or support life and pose a significant threat to a patient or provider’s health if used incorrectly. Class III devices must meet stringent guidelines, including premarket approval, in order to make it to the market. Among this category are silicone implants, implantable pacemakers, automated external defibrillators and replacement heart valves.
How to Determine What Class Your Medical Device Belongs In
As previously mentioned, the path to market for your medical device depends entirely on its classification. Unfortunately, classification isn’t so cut-and-dry, and you may have to do a bit of research to determine what category your particular device belongs in.
The FDA offers plenty of resources to assist you in this process, including a product classification database that contains roughly 1,700 different generic types of medical devices. Each device in the database contains information on its identification and classification, path-to-market requirements, and any applicable exemptions.
If searching the database seems like a rather daunting task, the FDA also breaks down this information by device classification panels, or medical specialities. Clicking on a specialty will lead you to a complete list of the devices associated with it. It’s a simpler way to navigate the information and find which pre-existing devices yours mostly closely resembles.
Steps to Take to Get Your Medical Device Registered With the FDA
Once you establish what class your medical device falls under, you can begin the process of getting it registered with the FDA.
Class I devices must satisfy all general controls to ensure they are safe, sanitary and follow good manufacturing processes. If your device meets these guidelines, you just need to register your company with the FDA and list all applicable devices manufactured by your company.
Class II devices must adhere to special controls as well as general controls unless marked as “exempt.” These special controls provide the FDA with additional assurance that your device is safe and effective, including extra measures like premarket data requirements, patient registries, performance standards and special labeling requirements. You must also fill out a 510(k), or a premarket submission, and disclose the product development process.
If you’re registering a Class III device, you will need to apply for what’s called premarket approval. Because Class III devices are classified carry higher risk, they need to meet stringent requirements before they are available for mass use. The FDA will need to thoroughly review your product and determine whether or not it is safe for the market.