CLIA and Regulatory Aspects of Assay Development

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CLIA and Regulatory Aspects of Assay Development 2016-11-10T20:22:29+00:00

Notable peer-reviewed articles—guidelines, definitions, information sources, and requirements for generation, assessment, and submission of proteomics data to regulatory agencies.


Articles of note

Proteomics quality and standard: from a regulatory perspective

Proteomics has emerged as a rapidly expanding field dealing with large-scale protein analyses. It is anticipated that proteomics data will be increasingly submitted to the U.S. Food and Drug Administration (FDA) for biomarker qualification or in conjunction with applications for the approval of drugs, medical devices, and other FDA-regulated consumer products. To date, however, no established guideline has been available regarding the generation, submission and assessment of the quality of proteomics data that will be reviewed by regulatory agencies for decision making. Therefore, this commentary is aimed at provoking some thoughts and debates towards developing a framework which can guide future proteomics data submission. Read more ›

Regulatory approval pathways for molecular diagnostic technology

This chapter describes the basic categories for regulatory approval to sell/market a molecular profiling technology. The US Food and Drug Administration regulates and provides guidance, for marketing in vitro diagnostic devices (IVD). Three different paths currently exist for obtaining Food and Drug Administration (FDA) approval of an IVD: (a) If the new test can be shown to be substantially equivalent to an existing predicate test on the market, then the 510(k) is the regulatory path for new device approval. (b) If your new diagnostic technology cannot be considered substantially equivalent to an existing technology, and will be used to make a critical medical decision concerning the diagnosis, treatment, or medical management, then the premarket approval (PMA) is the regulatory path of choice. (c) If no predicate device exists and the test is of low or moderate risk, it may be eligible for a de novo reclassification. Read more ›