Chapter 9 - Tests for genotoxicity

Abstract

Mutagenic or genotoxicity assessments is an important aspect of biological evaluation and assess the risk of cancer or any future generational abnormalities from exposure to medical devices. Genotoxicity assessments is essential for medical devices without existing or inadequate genotoxicity profiles. For medical devices with known genotoxin, further characterization on genotoxin release is required. These tests must be designed to investigate the classes of genetic damages caused by the medical devices and are required to factor in the analysis of chemical constituents of the device components. However, if all the components of the medical device haven been previously characterized chemically, with existing literature to attest the same, then assessments for genotoxicity can be waived from biological evaluation process. In this chapter, we attempt to depict the standard approach for assessment of potential mutagenicity of a test device.