FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines its regulatory pathway…
The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (21 CFR 860). A description of device classification and the Product Classification Database can be found at FDA website.
Class I devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.
Class II devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards.
Class III devices sustain or support life, so that their failure is life threatening.
This part briefly mentions some of the basic concepts involved in FDA regulation for medical devices in a sequence of the four medical device development stages. Full details are presented by the FDA on their Device Advice site.