Regulatory challenges for in vitro diagnostics in a global environment.
U.S. medical products are marketed globally and are designed to meet needs of medical practitioners and their patients throughout the world. However, differences in how these products are regulated in different countries can pose challenges for the global marketer. This paper explores some of the differences between proposed and extant U.S. and European regulations for in vitro diagnostic products in terms of documentation, records, and labelling. It will describe some of the practical implications of these differences.
Longwell
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Regulatory and Government Affairs, Becton Dickinson Immunocytometry Systems, San Jose, California 95131.
D019411:Clinical Laboratory Techniques / Q000145:classification / Q000191:economics / Q000379:methods / Q000592:standards*; D003257:Consumer Product Safety; D004282:Documentation; D005062:European Union; D016365:Liability, Legal; D011356:Product Labeling / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D011933:Reagent Kits, Diagnostic / Q000145:classification / Q000191:economics / Q000592:standards*; D014481:United States
D011933:Reagent Kits, Diagnostic