FDA has a public obligation to regulate and control the distribution of medical devices for public safety. To do this, medical device manufacturers provide information and data about their product to the FDA to assess the product for safety and effectiveness. However, not all products require the same level of review by the FDA. A low-risk product like a tongue depressor does not require the same level of regulatory oversight as a pacemaker.
There are three categories of medical device requirements or regulatory controls. The type of applicable regulatory controls is based on medical device classification. FDA medical device classifications are based on risk to the user. Class I medical devices are the lowest risk products (i.e., the tongue depressor), and Class III devices carry the most risk (i.e., the pacemaker).
Class I Medical Devices
FDA defines Class I medical devices as “not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury.” Examples of Class I medical devices include products like stethoscopes, bandages, and wheelchairs. These products are typically only subject to general controls.
General controls are requirements around adulterations, misbranding, registrations, banned devices, notifications, and other remedies, records, and reports. These are requirements a manufacturer must meet prior to marketing the medical device.
The FDA does not typically need to review safety or performance data regarding the safety and effectiveness of these products because these general controls are sufficient to provide a reasonable assurance of effectiveness and safety or because the device fits the definition of a Class I device.
Class II Medical Devices
Most medical devices are considered class II devices and present a moderate risk to the user, such as ultrasonic diagnostic equipment, x-rays, and needles. Class II medical devices are always subject to the same general controls as the class I devices.
Special Controls of Class II Medical Devices
Typically, class II medical devices are subject to special controls. Special controls are device-specific requirements and include compliance with performance standards, quality system regulations of 21 CFR Part 820, post market surveillance, patient registries, special labeling requirements, and premarket data requirements. Prior to marketing, data is submitted to the FDA through a premarket notification or a 510(k) submission. Upon review, the FDA notifies the manufacturer that the device is legally marketable.
Class III Medical Devices
Medical devices that cannot establish safety and effectiveness through general controls and special controls are class III devices. These devices are of the highest risk and include products such as balloon catheters, pacemakers, and heart valves.
Class III devices require a premarket approval application (PMA) from the FDA to thoroughly evaluate the medical device. PMAs typically requires clinical data and have a longer review process. Once the review is complete, the FDA will approve the medical device. Class III devices are typically life-sustaining, life-supporting, or long-term implantable devices.
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