ABSTRACT
Most of the regulatory interaction of a toxicologist involved in assessing the biocompatibility of devices is with the appropriate part of the Center for Devices and Radiological Health (CDRH), though for combination products the some centers charged with drugs or biological may also come into play. Medical devices are organized into three different classes and are regulated accordingly. The requirements for the safety evaluation and biocompatibility evaluation of devices have rapidly been becoming more sophisticated and closer to evaluations required for new drugs. The agency formally charged with overseeing the safety of devices and diagnostics in the United States is the CDRH of the Food and Drug Administration. The regulation of devices under the definitions has had a different history than that of drugs—it has not been as strict and has evolved at a slower rate.
