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FDA De Novo Classification Process (Evaluation of Automatic Class III Designation)

蒋千琴 2/4/2022 浏览 197 FDA US

标准简介

De Novo Classification Process (Evaluation of Automatic Class III Designation)[附网盘链接]是于之前发布的FDA标准，适用于US。

标准截图

De Novo Classification Process (Evaluation of Automatic Class III Designation)[附网盘链接]
De Novo Classification Process (Evaluation of Automatic Class III Designation)[附网盘链接](截图)

 

标准文档说明

标准文档类型为De Novo Classification Process (Evaluation of Automatic Class III Designation)[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

De Novo Classification Process (Evaluation of Automatic Class III Designation) Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration's (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. 1. Introduction The purpose of this document is to provide guidance on the process for the submission and review of a De Novo classification request (hereafter a “De Novo request”) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the De Novo classification process. This process provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. 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 guidances means that something is suggested or recommended, but not required. Throughout this guidance document, the terms “we,” “us” and “our” refer to FDA staff from the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) involved in the review and decision-making aspects of the De Novo classification process. “You” and “your” refers to the submitter of a De Novo request and/or related materials. 2. Background A device may be classified in class III and be subject to premarket approval (PMA) via several different regulatory vehicles. In accordance with the criteria at section 513(a)(1)(C)

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