FDA Deciding When to Submit a 510(k) for a Software Change to an Existing Device
标准简介
Deciding When to Submit a 510(k) for a Software Change to an Existing Device[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Deciding When to Submit a 510(k) for a Software Change to an Existing Device[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Deciding When to Submit a 510(k) for a Software Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance will assist industry and Agency staff in determining when a software (including firmware) change to a medical device may require a manufacturer to submit and obtain FDA clearance of a new premarket notification (510(k)). This guidance is not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required for a software change to a 510(k)-cleared device (or group of devices) or other device subject to 510(k) requirements, such as a preamendments device or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the Food, Drug, and Cosmetic Act (FD&C Act) (also referred to together as “existing devices”). Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision, specifically as it relates to software changes. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
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