The US Food & Drug Administration (FDA) is the primary regulatory body for medical plastics and the devices they are used to create. According to the administration’s own data, it regulates more than 6,000 medical devices, but it does not regulate them all the same. Medical devices are split into three regulatory categories, termed Class I, Class II and Class III. The devices are regulated depending their assigned class. This also determines whether the device is considered FDA Registered, FDA Listed, FDA Cleared, or FDA Approved.
How Medical Devices are Classified
Medical devices are placed into one of three classification buckets, depending on how much potential for harm the device possesses should it produce complications or not work properly. Here is a closer look at each classification:
- Class I – Class I devices are those with little or modest risk to the user or patient. About half of all medical devices are in this category. Of Class I devices, only five percent go through a premarket notification process. The other 95 percent can be marketed and sold without a premarket notification to the FDA. Examples of Class I devices include bedpans, manual stethoscopes and elastic bandages.
- Class II – Class II devices possess more potential risk for users than Class I devices. Slightly more than 40 percent of medical devices are placed in this category, and include things like infusion pumps, powered wheelchairs, and air purifiers. Most Class II devices require a premarket notification to the FDA. However, the regulatory process is not as demanding as it is for Class III devices.
- Class III – Class III devices often sustain or support human life, are implanted, or present high levels of risk to a person if they do not work properly or break. So, they carry substantial risk of serious injury or death should they fail. Only about 10 percent of devices are placed in the Class III category, and examples include replacement heart valves, cochlear implants, and many implanted electrical stimulation devices such as implanted cerebellar stimulators. The FDA regulates Class III devices to a degree it reserves for nothing else, so Class III devices must be proven to be safe, with supporting research data.
What FDA Listed, Registered, Cleared, and Approved Mean
Only a small portion of all medical devices go through an extensive regulatory process. Of the remaining devices, some proceed through a shorter, expedited process, while many do not require any premarket approval. The FDA uses words like listed, registered, cleared, and approved to differentiate between these processes and communicate the FDA’s involvement in the product’s approval. Here is what the terms actually mean:
- FDA Listed or FDA Registered – These synonymous terms are normally reserved for Class I devices that do not go through a premarket notification process. However, manufacturers are still required to list or register their product with the FDA, so if users or patients do experience adverse effects, the FDA can track the manufacturer down. That’s it, though, so when a device manufacturer states that their product is FDA listed or registered, that does not necessarily mean the product was tested. It just means that the manufacturer has informed the FDA of their product’s existence. In short, these terms do not say much about the product’s safety or effectiveness.
- FDA Cleared – If a manufacturer claims that their product has been cleared by the FDA, they are likely referring to a Class II device. Although some innovative Class II devices must go through the same tough premarket approval as Class III devices, this is not necessary in most instances.
Usually, a Class II device can be shown the same as a Class II device that already exists. In these cases, a manufacturer submits a premarket approval package to the FDA proving that the new product is the same as the previous product in form, fit, and function. The FDA reviews the application and clears the device to be marketed.
- FDA Approved – This term is reserved for devices that pass through the FDA’s most stringent reviews and analysis. As such, it is only seen on some Class II devices and any Class III device that has shown to be safe and effective. If a medical device has been FDA approved, that means it has been extensively tested for safety and effectiveness.
How the FDA Regulates Class III Devices
Bringing a Class I device to market is fairly quick, often taking less than a month. Class II devices normally take between six and nine months to clear. Class III devices, though, may be tested for a couple of years before the FDA approves them. Why does it take so long to approve a Class III device? It has to do with the regulatory process, which looks like this for Class III devices:
- Implement a Quality Management System, or QMS – Under the FDA’s 21 CFR Part 820, medical device manufacturers are required to implement a QMS before making a device. A QMS concerns the manufacturer’s processes, and not the product itself (or at least not directly). The QMS outlines things like design controls, material controls, equipment and facility controls, production controls, record keeping and how to implement corrective or preventative actions.
- Approval of an Investigational Device Exemption, or IDE – Before medical devices with significant potential safety risks are studied, the manufacturer has to get approval from the FDA to be able to use the device in a clinical study. The approved IDE limits the use of the device for the agreed upon clinical trials.
- Design clinical trial protocols and execute a study – This is the longest and perhaps the most difficult part of the regulatory process, but it is critical. How the clinical trials are designed and conducted are very important so that the people who are part of the clinical studies have limited risk from the device. Also, the information gathered during the trials has to show that the device is safe and effective for the device to get approved by the FDA.
- The FDA inspects the manufacturer’s facilities – The FDA will send regulators to the manufacturer and any of the manufacturer’s suppliers to verify that Quality Systems Regulations (QSR) are fully implemented at every facility.
- Premarket approval is granted or denied – After reviewing the available trial data and inspecting the manufacturer’s facilities, the FDA will either approve the product or deny approval. If approval is given, the manufacturer must register their company and list the device before selling the product.
FDA regulation of medical devices is regularly updated. Always refer directly to the FDA’s website and publications for their most up-to-date regulatory policies and information.