Introduction to In Vitro Diagnostic Device Regulatory Requirements

  • Jonathan DayEmail author
Part of the Methods in Molecular Biology book series (MIMB, volume 949)


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.

Key words

In vitro diagnostic device FDA regulations 510K EU regulations CE marking Quality management systems 

Copyright information

© Springer Science+Business Media,LLC 2013

Authors and Affiliations

  1. 1.DNA Electronics Ltd, Institute of Biomedical EngineeringImperial CollegeLondonUK

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