The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices.

The 57-page guidance, Design Considerations for Pivotal Clinical Investigations for Medical Devices, was first released in draft form August 2011 and pertains to the stages of development in which a device is evaluated for safety and efficacy, otherwise known as the pivotal stage of development.

In general, such studies are used to support premarket approval applications (PMAs), but a smaller subset may also be used to support premarket notification [510(k)s] and de novo submissions as well.

As explained by FDA, the guidance elaborates on various "principles" of study design that will meet FDA's expectations for premarket clinical data requirements, but regulators stressed it is not meant as a "comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies."

The guidance is divided into seven sections, with several containing extensive sub-sections:

• Regulatory Framework for Level of Evidence and Study Design
• Types of Medical Devices
• The Importance of Exploratory Studies in Pivotal Study Design
• Some Principles for the Choice of Clinical Study Design
• Clinical Outcome Studies
• Diagnostic Clinical Performance Studies
• Sustaining the Quality of Clinical Studies
• The Investigational Plan or Protocol

Design Considerations for Pivotal Clinical Investigations for Medical Devices

Federal Register