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FDA Bundling Multiple Devices or Multiple Indications in a Single Submission

蒋千琴 11/15/2021 浏览 236 FDA 美国

标准简介

Bundling Multiple Devices or Multiple Indications in a Single Submission[附网盘链接]由FDA于之前发布，适用于美国。

标准截图

Bundling Multiple Devices or Multiple Indications in a Single Submission[附网盘链接]
Bundling Multiple Devices or Multiple Indications in a Single Submission[附网盘链接](截图)

 

标准文档说明

标准文档类型为Bundling Multiple Devices or Multiple Indications in a Single Submission[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

Bundling Multiple Devices or Multiple Indications in a Single Submission 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. Background The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-

250, amended the Federal Food, Drug, and Cosmetic Act (the act) by authorizing FDA to collect user fees for certain premarket submissions received on or after October 1, 2002. A letter from the Secretary of Health and Human Services to Congress that accompanies the user fee legislation sets forth performance goals and policy and procedural provisions. One of these provisions is entitled, “Bundling Policy,” and states that FDA will consider, in consultation with its stakeholders, when bundling multiple devices in a single submission may be appropriate. Prior to MDUFMA, submitting separate applications for devices that could have been bundled in a single submission, or bundling of devices that should have been submitted in separate applications, was primarily an administrative issue related to the efficiency of the review process. Under MDUFMA, bundling within a single premarket submission takes on additional importance because of the fees that are now associated with premarket submissions as well as the performance goals that the agency has committed to meet. This guidance is intended to assist industry and FDA staff in understanding when bundling may be appropriate. This guidance will be used by both the Center for Devices 4

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