GUIDANCE DOCUMENT
Design Considerations for Pivotal Clinical Investigations for Medical Devices Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff November 2013
- Docket Number:
- FDA-2011-D-0567
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
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