FDA Medical Device Classes Overview
If you were to undergo a pacemaker implant procedure, you would want assurance that the medical device to be surgically implanted into your body is subjected to a more intensive approval process than a less critical medical component like a set of surgical gloves. For this reason, FDA regulates all medical equipment sold in the United States, dividing them into three categories. Based on the risk involved, invasiveness, and influence on the patient’s general health, each medical device authorized by the FDA is categorized as Class I, II, or III. But how are the boundaries between these three classes established, and why?
FDA Medical Device Classes
The Food and Drug Administration (FDA) has categorized over 1,700 distinct generic device types into 16 medical classifications. Each of these broader categories of devices is further allocated into one of three classes depending on the amount of control required to ensure the device’s safety and efficacy.
The device categorization is determined by its intended application as well as its indications for usage. A scalpel, for instance, is designed to cut tissue. When a more specialized indication is appended to the device’s labeling, such as for cutting tissue in the eye, a subclass of intended uses emerges. Furthermore, categorization is risk-based, which means that the danger posed by the device to the patient and/or the user is a primary factor in the class to which it is allocated. Class I equipment pose the lowest risk, while Class III devices have the highest risk.
It’s critical to know the categorization of your device from the start because it will indicate the regulatory restrictions you must follow to create safe and effective medical equipment. Omnica manufactures Class 1, 2, and 3 medical devices and prototypes in Los Angeles. So, let’s break them down.
FDA Class I
Class I devices are medical devices that are not indicated for deployment in sustaining or supporting life or alleviating health issues in the user, and they do not carry the risk of injury or illness with proper use. Class I devices do not make contact with a patient’s inner organs, neurological system, or cardiac system. Class I devices face the lightest regulatory restrictions and are the easiest to approve for market availability.
Examples of Class I medical devices include:
- Hospital beds
- Oxygen masks
- Tongue depressor
Class I medical devices are not subject to premarket notification or premarket approval. However, they are subject to general controls which apply to all classes of medical equipment. This regulation covers tampering, mislabeling, device registration, record keeping, and proper manufacturing procedures. Class I device manufacturers must develop a quality assurance system and adhere to standards to ensure high-quality products.
FDA Class II
Class II devices raise a medium to high risk to the user or patient. This group encompasses 43% of all medical equipment, which constitutes the majority of medical equipment. Devices that make contact with a patient’s internal tissues or circulatory system, as well as diagnostic instruments, fall under this category. Some examples of Class II devices are catheters, pregnancy test kits, contact lenses, and surgical gloves.
The FDA defines devices in this class as devices for which general controls are inadequate in ensuring the device’s safety and efficacy. As a result, Class II devices must adhere to special controls, as well. Depending on the device, patient registries, special labeling, and performance criteria may be included in these guidelines.
The Premarket Notification (510k) protocol is used to bring most Class II products to market. This FDA application intends to prove that a device is safe and efficacious by establishing a reasonable comparison to other devices on the market.
FDA Class III
High-risk devices, most of which come into prolonged contact with human internal systems, are classified as Class III. Class III devices are items that typically preserve or sustain life, are implantable, or carry a possible unjustifiable risk of harm or illness. Only 10% of all medical devices fall under Class III.
This includes implants such as pacemakers and sophisticated medical equipment like defibrillators. Class III devices must undergo the most rigorous approval process before entering the market. In addition to general and special controls, these devices must gain premarket approval. The premarket approval process involves an intensive data gathering process—typically through clinical trials—to determine the risks and benefits associated with the device.
Contact Omnica for FDA Medical Device Clarification
Medical device categorization provides critical information for users on the proper usage and implied risk of the device they intend to use. Regardless of your device’s categorization, you must adhere to the regulatory rules. Meeting compliance is an important part of quality control that will eventually determine whether your device makes it to market.
We at Omnica Corporation recognize the significance of medical device quality control. We specialize in the development of Class I, II, and III medical devices, and are experts in the design processes for each classification. To learn more about our capabilities, contact us today.
Who We Are
Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.
Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.