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FDA Annual Reports for Approved Premarket Approval Applications (PMA)

蒋千琴 10/17/2021 浏览 172 FDA 美国

标准简介

Annual Reports for Approved Premarket Approval Applications (PMA) [附网盘链接]由Food And Drug Administration于之前发布，适用于美国。

标准截图

Annual Reports for Approved Premarket Approval Applications (PMA) [附网盘链接]
Annual Reports for Approved Premarket Approval Applications (PMA) [附网盘链接](截图)

 

标准文档说明

标准文档类型为Annual Reports for Approved Premarket Approval Applications (PMA) [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

Contains Nonbinding Recommendations Annual Reports for Approved Premarket Approval Applications (PMA) 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 Devices subject to premarket approval (PMA) under section 515 of the Federal Food, Drug, and Cosmetic Act (the Act) are subject to periodic reporting requirements set forth in the PMA approval order (21 CFR 814.82(a), 21 CFR 814.84(b)). This guidance document describes the information required to be submitted in annual reports under 21 CFR 814.84(b), additional information requirements that may be imposed by approval order under 21 CFR 814.82(a), and FDA’s recommendations for the level of detail the applicant should provide in the annual report. It also identifies the steps FDA staff generally take when reviewing annual reports, the resources available to assist staff in their reviews, and the actions they may recommend after reviewing annual reports. This guidance document is intended to help ensure that annual reports are complete and that the actions of CDRH and CBER staff are consistent. 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.

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