An Overview of the Investigational Device Exemption Regulation
Abstract
An Investigational Device Exemption (IDE) is required of most medical devices that are to be clinically investigated to determine their safety and effectiveness. Several types of devices are exempt from the requirement, and nonsignificant-risk devices have abbreviated requirements. The IDE regulation is discussed and a source of additional information is listed.
- Copyright © 1982 by the American Diabetes Association
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In this Issue
May 1982, 5(3)
An Overview of the Investigational Device Exemption Regulation
