title: Introduction to in vitro diagnostic device regulatory requirements.
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.
authors: DNA Electronics Ltd, Institute of Biomedical Engineering, Imperial College, London, UK. jonathan.day@dnae.co.uk
authors: Jonathan
authors: J
authors: Day
mesh_terms: D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation* / Q000592:standards; D005062:European Union; D033161:Government Regulation; D006798:Housing; D038622:Internationality; D046210:Microfluidic Analytical Techniques / Q000295:instrumentation* / Q000592:standards; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012106:Research / Q000295:instrumentation; D018570:Risk Assessment; D012926:Social Control, Formal; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D011933:Reagent Kits, Diagnostic