ABSTRACT
To an even greater extent than is the case with pharmaceuticals, the regulatory nonclinical safety assessment requirement (called, for devices, biocompatibility evaluation) has become globally harmonized. The primary guidance for the United States, European Union and Japan and associated countries have formally become the ISO-10993 standards with each having reference to their own regulations only in special cases (of which there are a number). The remainder of the world has chosen to follow suit, making adherence of testing to support a submission primarily by reference to the International Standards Organization (ISO) standards.
