2. How does FDA classify medical devices?
In accordance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices into one of three regulatory classes based on the level of control necessary to ensure safety and effectiveness of the device. Classification is risk based, that is, the risk the device poses to the
patient and/or the user is a major factor in determining the class to which it is assigned.
Devices in all three classes are subject to general controls which require, in part, that companies:
(1) register their establishments and list the medical devices they market with FDA;
(2)manufacture their devices in accordance with Good Manufacturing Practices; and
(3) label their devices in accordance with labeling regulations.
Class I devices are subject only to general controls. They typically present the lowest potential for harm and are simpler in design than Class II or Class III devices.
Examples of Class I
devices include elastic bandages, examination gloves, and hand-held surgical instruments.