Class I and Class II Medical Devices
Medical devices consist of three classifications, recognized by the Food and Drug Administration (FDA), with different regulatory controls: Class I, Class II and Class III. The classification of each product depends on the intended use and the indications for use of the medical device.
Class I Devices
Class I devices are only subject to “General Controls” and are the least regulated. The Class I classification of medical devices is not intended for use in assisting, supporting or sustaining life. Class I devices would consist of bandages, exam gloves and similar medical devices that assist in the medical, dental and surgical fields.
Class II Devices
Class II devices are subject to “General and Special Controls”. Special controls can include required labeling, performance standards and aftermarket validation of the medical device. Examples of Class II devices can include powered wheelchairs, joint prosthesis and infusion pumps.
To read more about medical class device procedures and regulations visit the FDA’s webpage on Device Classifications.