Introduction to in vitro diagnostic device regulatory requirements.

Jonathan Day

DNA Electronics Ltd, Institute of Biomedical Engineering, Imperial College, London, UK. jonathan.day@dnae.co.uk

Methods in molecular biology (Clifton, N.J.) 2013

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A common application for microfluidics can be found in medical devices where the advantages of small volume measuring equipment can be exploited for In Vitro Diagnostics. This chapter focuses on the US and the EU regulations, explaining the broad landscape and regulatory pathways of each market.