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FDA Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad

蒋千琴 11/5/2021 浏览 146 FDA United States

标准简介

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。

标准截图

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad[附网盘链接]
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad[附网盘链接](截图)

 

标准文档说明

标准文档类型为Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad[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

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics 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 A submitter of a premarket notification submission (510(k)) must demonstrate to the Food and Drug 1

Administration (FDA) that the “new device” is “substantially equivalent” (SE) to a legally 2

marketed predicate device. This guidance is intended to help 510(k) submitters demonstrate substantial equivalence. This guidance does not add new regulatory requirements for submitters, it does not change the 510(k) premarket review standard nor does it create extra or new burdens on what has traditionally been submitted in 510(k)s. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. Furthermore, this document is intended to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate device. The benefit-risk profile of a new device does not need to be identical to the predicate device for it to be SE to the predicate device. This document is intended to provide guidance when the benefit-risk profile of a new device is different from that of the predicate device. More specifically, FDA believes this document can be helpful in situations when there is 1) an increase in risk and increase or equivalent benefit or 2) a decrease in benefit and a decrease or equivalent risk when comparing a new device to a predicate device. In these situations, a benefit-risk assessment should be conducted comparing the benefits and risks of a new device to a predicate device. Such assessments may aid in 1

In this guidance, “SE” also refers to “substantial equivalence.” 2

See section 513(i) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (21 U.S.C. § 360c(i)).

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