Summary

This chapter discusses regulatory frameworks for genetic tests, in particular the systems for regulating medical devices and clinical laboratories. It describes concerns about genetic testing that have led to calls for enhanced regulation and considers recent developments in regulation. It identifies features of regulatory systems in several jurisdictions, including the UK, the USA, the European Union, Canada and Australia. The chapter concludes by discussing several different policy options that are emerging both from developments in regulatory systems and policy debates surrounding genetic testing. These options include: pre-market review and post-market controls; genetic test and laboratory registries; enhanced roles for third parties; and consumer education.

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