Hello everyone and welcome back to MedTech Compliance Chronicles. Now that we have determined our product is a medical device the next step is to figure out which class it falls under. FDA regulates medical devices in three classes, I, II and III with increased regulations the higher the class. In this post we will focus on how the FDA distinguishes between the three classes and what each one means and entails.
First, we’ll get into what the FDA is really looking for in device classification and what the overall goal and intent is. FDA regulates medical devices to ensure that devices sold in the United States are safe for the intended users and patient population and effective for its intended use. The FDA uses objective, scientific evidence in order to gain confidence that a device is safe and effective to market. The increasingly stringent regulations with each class result from the fact that, as the risk a device presents increases, the FDA needs commensurately more evidence provided by the manufacturer to have confidence that the device is safe and effective. Next we’ll dive into what the different classes mean and how they are divided up to meet this goal of assuring safety and effectiveness.
General Controls
The different classes of device are based on the amount of controls FDA finds necessary to feel confident your device is safe and effective. We will start with ‘general controls.’ General controls are applicable to all medical devices (except for certain exemptions which will be covered in later posts). I will dive deeper into what the general controls are now but I won’t go into detail about any of the particular processes to implement them, they will all be the topics of later blog posts.
The first sections of general controls emphasize ‘adulterated’ and ‘misbranded’ devices. What exactly falls into these can confuse some initially. Adulteration of a device essentially means that it has failed to meet safety and effectiveness standards which apply to it. This includes a lot of things, essentially, if it fails to meet any of its requirements and you have not documented a justification for the deviation and taken steps to assure that this deviation can occur without new or increased risk associated with the device, then the device is adulterated. Some examples of what types of requirements you will have to follow include regulations, the various parts of Title 21 that are applicable to your device. Requirements the manufacturer has deemed necessary are bound once documented (and they must be documented), these would include design outputs, process parameters and anything else the manufacturer has deemed necessary to the manufacture of the device. Where applicable, when international consensus standards such as ISO or IEC are relevant to your device these could also represent requirements you must meet or justify not meeting. Misbranding of a device is much simpler to understand. Basically, your device is misbranded if it does not comply with labeling requirements.
The next section of general controls most people know from its subsection (k), 510 is actually a more general section about registration of producers of devices. As a medical device manufacturer, you are required to register your establishment and all medical devices you market with the FDA. These registrations help the FDA maintain a list of medical device manufacturers which market inside the USA as well as a list of all medical devices currently on the market. In addition to gathering useful data, this information is critical if and when issues occur with devices during use to facilitate getting the patient the correct information, making the manufacturer aware of the defect in their product and, if necessary, to facilitate recalls.
The remaining general controls establish requirements for device tracking and Unique Device Identification(UDI), post-market surveillance and device reporting. They also require a manufacturer to follow current good manufacturing practices, which we will go into great detail when we get into the posts about establishing your Quality Management System(QMS). As with the previous set of general controls these requirements help the FDA build and maintain data sets that track the safety and effectiveness of all types of medical devices, as well as help easily facilitate safety alerts and recall notices. These requirements are also quite helpful to the manufacturer when it comes time for root-cause investigations and analyzing failure trends in the field.
Now, back to classification. If doing only these things, meaning complying with only the general controls, is enough to provide the FDA with sufficient confidence of the safety and effectiveness of your device, then your device is class I. We will next go into ‘special controls,’ the defining difference for class II devices.
Special Controls
Special controls, as the name kind of implies, are additional ‘controls’ or activities that must be performed when producing class II devices that provide the FDA with additional confidence of the safety and effectiveness of the device. Special controls are established for devices which present a higher risk to patient and/or user health than class I devices but lower than class III devices. If you are coming from other regulatory markets where device classification is done based on the technology inherent in the device or the way the device is used, you may be surprised by some devices which fall under class II in the United States. This is because as soon as performance standards exist which guarantee safety and performance to an acceptable level for a given device, even a class III device, those performance standards can be made into special controls and the device reclassified to class II.
In addition to specific performance standards, special controls can include specific labeling requirements, establishment of patient registries and additional post-market surveillance activities. For higher risk devices they can even include on-going post-market clinical trials. The thing to remember about special controls is that they are specific to a generic device type. For each generic device type that falls under class II, the specific special controls can be found on the FDA’s website. Specifics on special controls are not planned to be the topics of any future posts as they are specific to certain devices. A device is considered class II when special controls and general controls alone are enough to provide the FDA with confidence of the device’s safety and effectiveness.
Class III
Finally, we have the final category of devices, essentially everything that special controls either don’t exist for or still do not provide reasonable assurance of safety and effectiveness, also known as class III. In general class III devices are high risk profile and usually are involved in supporting or sustaining human life. Two other aspects of your device that can put you into the class III category are if your device poses a potentially unreasonable risk to human health or if the technology around your device is relatively new and little is known about it. It should also be noted that all new devices that register with the FDA without a ‘predicate device’ are initially classified as class III unless a De Novo request is submitted. The defining characteristics for class III devices are high risk and the non-existence of adequate performance standards to control this risk.
Conclusion
This concludes our exploration of how and why the FDA classifies medical devices. The FDA has established a general set of regulations and 'controls' that are applicable to all medical devices. Class I devices are devices for which just these regulations alone provide enough evidence of the safety and effectiveness of the device. If the general controls alone do not provide enough confidence then the next question to ask is, are there specific performance standards for this type of device which guarantee safety and performance to an acceptable level? If so, the device is likely class II unless life supporting or life sustaining. If not, or if your device is life supporting or life sustaining, you might be entering class III. Class III devices face far more scrutiny up front with the pre-market approval process, as well as require more intense post-market activities.
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