Device Regulatory Classes

Medical devices are assigned to regulatory classes based upon intended use and indications for use, which impact the level of regulatory control required. The FDA has created about 1700 different generic device types, grouping these into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes.

Class I—Regulatory Controls: These devices are subject to the least regulatory control as they usually have a simple design and present minimal potential for harm. Examples include examination gloves, elastic bandages, and urine collecting bags. Most Class-I devices are exempt from 510(k) or GMP controls.

Class II—Special Control: Class-II devices, such as motorized wheelchairs, infusion pumps, surgical drapes, and some home pregnancy test kits, require additional regulation in order to ensure proper design and performance standards. Such devices may require special labeling and postmarket surveillance. Most medical devices fall into this category.

Class III—Premarket Approval: Devices that support or sustain life or present a significant risk of illness or injury fall under the Class-III category. Implants, such as pacemakers and silicone gel breast implants, are Class-III products, as are internal tissue adhesives, thermal ablation devices, synthetic ligaments and tendons, vacuum pumps, and prosthetic hips. Class-III accounts for about 10% of all medical devices.

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