The FDA17 has established classifications for approximately 1700 different generic types of devices, and grouped them into 16 medical specialties, referred to as panels. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device: Class I, Class II, and Class III. The classifications are assigned by the risk the medical device presents to the user and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risks to the user and FDA regulatory control also increase. Accessories to medical devices and devices/products used with a medical device to support the use of the device are considered the same classification as the medical device.
The class to which a device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If the device is classified as Class I or II, and if it is not exempt,18 a 510(k) will be required for marketing. All devices classified as exempt, are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR §862-§892. For Class III devices, a PMA application will be required unless the device is a preamendment device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) AND a PMA submission has not been requested by FDA.
Device classification depends on the intended use19 of the device and also upon its indications for use. For example, a scalpel’s intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device’s labeling such as, “for making incisions in the cornea”. Indications for use can be found in the device’s labeling, but may also be conveyed orally during sale of the product.
Device classification is risk-based, that is, the risk the device poses to the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As noted earlier, all device classes are subject to General Controls which are the baseline requirements of the Food, Drug and Cosmetic Act.
The Device Classes are as follows:
• Class I—General Controls
• Class II—Special Controls
• Class III—Premarket Approval