Abstract
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.
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© 2013 Springer Science+Business Media,LLC
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Day, J. (2013). Introduction to In Vitro Diagnostic Device Regulatory Requirements. In: Jenkins, G., Mansfield, C. (eds) Microfluidic Diagnostics. Methods in Molecular Biology, vol 949. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-134-9_7
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DOI: https://doi.org/10.1007/978-1-62703-134-9_7
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Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-62703-133-2
Online ISBN: 978-1-62703-134-9
eBook Packages: Springer Protocols