Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff

Issue Date: April 11, 2008
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Investigational Device Exemption (IDE), Orthopedic
Status: Final

Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff

This document was developed to describe our recommendations for IDE applications for total artificial disc devices. It provides guidance for developers on the appropriate pre-clinical tests and clinical trial designs to adequately evaluate the safety of these devices as well as their effectiveness to relieve symptoms of spinal etiology and improve quality of life. This document makes additional recommendations and supplements “Guidance Document for the Preparation of IDEs for Spinal Systems” (i.e., Spinal Systems Guidance). The purpose of this document is to provide guidance to industry sponsors and FDA staff about important preclinical and clinical information, which should be presented in an Investigational Device Exemption (IDE) application for total intervertebral disc replacement systems (i.e., total artificial discs). FDA is issuing this document to help ensure consistency and understanding between FDA and sponsors when developing IDE submissions for total artificial discs. We hope this guidance will conserve FDA and industry resources and facilitate timely review.

Download the Guidance Document