The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance on IDE Policies and Procedures

Short Title:
Medical Devices, IDE
Origin/Publisher:

FDA

Document Type:
Guidance
Content:
This document is intended to provide guidance1 to Office of Device Evaluation (ODE) reviewers on issues frequently encountered during the review of Investigational Device Exemptions (IDE) applications.

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