米食品医薬品局（FDA）は「医療機器向けソフトウェアの機能に関する新しい指針案」を公表 - June 2023

16年前に発行された「Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices」（医療機器に含まれるソフトウェアの市販前提出書類の内容に関するガイダンス）に代わるものです。

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This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions, which considers current standards and best practices. The recommendations in this guidance are intended to facilitate FDA’s premarket review. This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.

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download (fda.gov)