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In this chapter, an overview of the regulatory requirements to place medical devices on the market in the USA is presented. Important legislation is discussed as well as introducing the role of the Food and Drug Administration (FDA). General controls, which are applicable to manufacturers of all medical devices, are presented along with further measures for higher-risk devices. Different regulatory pathways are discussed as well as the central role the FDA product codes play in the selection of the correct regulatory pathway. Public resources made available from the FDA are presented to assist the reader in locating further information. While the reader can use this chapter as an introduction, it is essential that manufacturers who intend to enter this market research this topic in depth and ensure their compliance with all applicable US laws.

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Regulation of Medical Devices in the USA with a Focus on IVDs

  • 章节

  • 发表日期：

    2026年

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  • Jennifer Dean,
  • Sabine Schumann-Hahn

摘要

In this chapter, an overview of the regulatory requirements to place medical devices on the market in the USA is presented. Important legislation is discussed as well as introducing the role of the Food and Drug Administration (FDA). General controls, which are applicable to manufacturers of all medical devices, are presented along with further measures for higher-risk devices. Different regulatory pathways are discussed as well as the central role the FDA product codes play in the selection of the correct regulatory pathway. Public resources made available from the FDA are presented to assist the reader in locating further information. While the reader can use this chapter as an introduction, it is essential that manufacturers who intend to enter this market research this topic in depth and ensure their compliance with all applicable US laws.