FDA Design Considerations for Pivotal Clinical Investigations for Medical Devices Industry, Clinical Investigators, Institutional Review Boards and FDA Staff

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Design Considerations for Pivotal Clinical Investigations for Medical Devices Industry, Clinical Investigators, Institutional Review Boards and FDA Staff[附网盘链接]是FDA于之前发布的FDA标准，适用于美国。

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Design Considerations for Pivotal Clinical Investigations for Medical Devices Guidance for Industry, Clinical Investigators, 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. 1 Introduction This document is intended to provide guidance to those involved in designing clinical studies intended to support pre-market submissions for medical devices and FDA staff who review those submissions. Although the Agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement, the Agency has not attempted to describe the different clinical study designs that may be appropriate to support a device pre-market submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill pre-market clinical data requirements. This guidance is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies. Medical devices can undergo three general stages of clinical development. These stages may be extremely dependent on each other and doing a thorough evaluation in one stage can make the next stage much more straightforward. To begin, medical devices may undergo an exploratory clinical stage. In this stage, the limitations and advantages of the medical device are evaluated. This stage includes first-in-human studies and feasibility studies. The next stage, the pivotal stage, is used to develop the information necessary to evaluate the safety and effectiveness of the device for the identified intended use. It usually consists of one or more pivotal studies. Finally, devices undergo a post-market stage which can include an additional study or studies for better understanding of device safety, such as rare adverse events and long-term effectiveness. This guidance provides information on design issues related to pivotal clinical investigations and does not address the other stages in any detail.

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