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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.