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FDA Deciding When to Submit a 510(k) for a Change to an Existing Device

蒋千琴 2/5/2022 浏览 193 FDA 美国

标准简介

Deciding When to Submit a 510(k) for a Change to an Existing Device[附网盘链接]由Food&Drug Administration于过去发布，适用于美国。

标准截图

Deciding When to Submit a 510(k) for a Change to an Existing Device[附网盘链接]
Deciding When to Submit a 510(k) for a Change to an Existing Device[附网盘链接](截图)

 

标准文档说明

标准文档类型为Deciding When to Submit a 510(k) for a 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 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 Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the Agency) has attempted to define with greater clarity when a change in a medical device would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the Agency. This document supersedes FDA’s guidance Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued on January 10, 1997. 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. 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. 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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