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FDA Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval

蒋千琴 11/4/2021 浏览 182 FDA 美国

标准简介

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval[附网盘链接]是于过去发布的FDA标准，适用于美国。

标准截图

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval[附网盘链接]
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval[附网盘链接](截图)

 

标准文档说明

标准文档类型为Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval[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

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction  

This guidance clarifies the Food and Drug Administration’s (FDA or the Agency) current policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval while still meeting the statutory standard of 1

reasonable assurance of safety and effectiveness. The right balance of premarket and postmarket data collection facilitates timely patient access to important new technology without undermining patient safety. FDA believes this guidance document will improve patient access to safe and effective medical devices that are important to the public health by improving the predictability, consistency, transparency, and efficiency of the premarket review process. This guidance document is intended to support FDA’s efforts to enhance timely availability of devices subject to premarket approval. This guidance describes FDA’s existing statutory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), its implementing regulations, and current policies that support this policy. In addition, FDA clarifies how FDA considers postmarket data as part of the benefit-

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See section 515(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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