an individual patient or an individual health-care practitioner. A new industry that has emerged in the United States reprocesses single-use disposable devices and reintroduces them into interstate commerce as new, and these are subject to the same FDA regulatory review processes as the original devices. Similarly, there is an industry that remanufactures durable medical equipment, including some class III medical devices, and reintroduces them into interstate commerce.

The system of identifying generic types of devices and classifying them is critical for the successful regulation of such diverse products. It is an efficient means for the agency to allocate its resources and maximize FDA’s effect on public health.

Safety and Effectiveness

The same definitions of safety and effectiveness apply to all medical devices, whether they are in class I, class II, or class III. How safety and effectiveness are determined is outlined by statute and regulation. Factors that are taken into consideration include the intended patient population, the conditions of use that are communicated through labeling and advertising, the balance of health benefits and risks associated with use of a device, and the reliability of the device.

For FDA to allow a product to be marketed in the United States, there must be

  • Reasonable assurance of safety. The probable benefits derived from the use of the product must outweigh the probable risks; there must be an absence of unreasonable risk of illness or injury associated with the use of the product.

  • Reasonable assurance of effectiveness. Use of the product must yield clinically significant results in a significant portion of the target population.

Device Classification

The approach to ensuring safety and effectiveness depends heavily on a device’s classification. Class I devices are subject to general controls, class II to special controls, and class III to premarket approval.

Phillips pointed out that premarket notification is the general control that gives the agency an opportunity to determine whether a new product falls into an existing generic type of device or should be considered as a different generic type (it could be in class III, or it could be the subject of a de novo or reclassification effort and be in class I or class II).

Generic type of device is defined by regulation and means a group of



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