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Abstract:
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Regulation of medical devices, including in vitro diagnostic devices, varies by region. For more than 13 years, efforts to harmonize various requirements for devices have been ongoing under the auspices of the Global Harmonization Task Force. We will discuss the structure and function of the GHTF and note the relevance of statistical and study design differences across regulatory authorities. In one study group, a statistical document was developed to assist in deciding whether to send reports to regulators concerning trends in adverse events. Finally, harmonization efforts for emerging technologies, such as nanotechnology and pharmacogenomic Rx/Dx codeveloped products, will be discussed.
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