FDA Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A
标准简介
Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A[附网盘链接]是FDA发布的FDA标准，适用于U.S。标准截图
![Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A[附网盘链接]](/img/20210914103605ytq3g.jpg)
标准文档说明
标准文档类型为Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A[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
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A 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 document provides the Center for Devices and Radiological Health (CDRH or the Center) interpretation of key provisions set forth in section 517A of the Federal Food, 1
Drug, and Cosmetic Act (FD&C Act), as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75. 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. II. Background
Section 517A of the FD&C Act contains provisions for the documentation and review of certain decisions in the premarket review of device submissions. Specifically, this provision states: 1
Section 517A of the FD&C Act was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, and subsequently amended by sections 3051 and 3058 of the 21st Century Cures Act of 2016.
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