Medical Devices

Medical Devices Development

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

Low Risk Devices: Non-life sustaining. These products are the least complicated and their failure poses little risk to the user.

CLASS II

Medium Risk Devices: More complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to many general and specific performance standards

CLASS III

High Risk Devices: Sustain or support life, their failure is life threatening.