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Most medical devices in the US today are marketed under the premarket notification (510(k)) authorities of the Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to what is required in other jurisdictions, the regulatory requirements and the submission process are very different.

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  • Fundamentals of US Regulatory Affairs, 10th Edition
    The 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters on drugs and medical devices, biosimilars, and traceability and supply chain.
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    Derived from the 10th edition of Fundamentals of US Regulatory Affairs, this book focuses on legislation and regulations for medical devices in the US. It also examines US Food and Drug Administration’s (FDA) history and the development of the regulatory environment, and the regulatory pathways available for all healthcare product submissions. Both devices and in vitro diagnostics (IVDs) are included in this volume.
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    This definitive guide to the most common terms and definitions in the US regulatory field is ideal for new and experienced regulatory professionals. Whether you’re looking for the acronym for a new regulation or the definition of an industry-specific term or a drug, you’ll find an entry for relevant vocabulary across the regulatory spectrum.

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