In Focus: The Future of In Vitro Diagnostics

Posted 01 May 2011 | By Robert Schiff, PhD, RAC, CQA, FRAPS 

The May issue on in vitro diagnostics brings a variety of articles from very experienced authors in the regulatory area.According to the US Food and Drug Administration (FDA), "In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body." They are still medical devices and most are administered under the Center for Devices and Radiologic Health (CDRH). However, those involving the blood supply are reviewed by the Center for Biologics Evaluation and Research (CBER).

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