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FDA Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

蒋千琴 2/14/2022 浏览 244 FDA U.S

标准简介

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

标准截图

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions[附网盘链接]
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions[附网盘链接](截图)

 

标准文档说明

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标准部分原文

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions 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 is intended to help Food and Drug Administration (FDA) staff develop a request for additional information needed to make a decision on a medical device marketing application in accordance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act (FD&C Act). Such an FDA request for additional information is known as a “deficiency.” In addition, this guidance describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests, in order to make efficient use of industry and FDA’s time. This guidance includes examples of well-constructed deficiencies and industry responses to facilitate an efficient review process. This guidance also details supervisory review, major/minor deficiencies, additional considerations, and prioritization of deficiencies in FDA deficiency letters. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 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. Throughout this guidance document, the terms “we,” “us,” and “our” refer to FDA staff from the Center for Devices

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