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  • Feature ArticlesFeature Articles

    Fundamentals and Global Impact of 510(k) for Medical Devices

    This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers. Introduction The expansion of the global medical device healthcare market has been evolving rapidly in the 21st century Notably, clinical chemistry analyzers and in vitro diagnostics are estimated to reach $11.7 billion and $75.1 billion respectively by 2019 and 2020. 1, 2 Despite attractive opportunitie...
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    Nanomedicine: Current Regulatory Scenario and Prophylactic Regulatory Strategies

    "According to Global Industry Analysts Inc. report on nanomedicine, commercialization of this tiny technology is surging at a steady rate and is expected to exceed $160 billion by 2015." 1 What is Nanomedicine? In simple terms, nanomedicine (NM) is nanotechnology-enabled medicine. 2 It is the science and technology of diagnosing, curing and preventing a disease, repairing damaged tissues and preserving human health using molecular tools and molecular knowledge of the ...